{"id":"https://openalex.org/W4415364752","doi":"https://doi.org/10.3389/jpps.2025.14721","title":"A survey of regulatory recommendations for waivers of in vivo bioequivalence studies of generic products for certain dosage forms by participating regulators and organisations of the International Pharmaceutical Regulators Programme. Part 2","display_name":"A survey of regulatory recommendations for waivers of in vivo bioequivalence studies of generic products for certain dosage forms by participating regulators and organisations of the International Pharmaceutical Regulators Programme. Part 2","publication_year":2025,"publication_date":"2025-10-20","ids":{"openalex":"https://openalex.org/W4415364752","doi":"https://doi.org/10.3389/jpps.2025.14721","pmid":"https://pubmed.ncbi.nlm.nih.gov/41189551","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/12580124"},"language":"en","primary_location":{"id":"doi:10.3389/jpps.2025.14721","doi":"https://doi.org/10.3389/jpps.2025.14721","is_oa":true,"landing_page_url":"https://doi.org/10.3389/jpps.2025.14721","pdf_url":"https://www.frontierspartnerships.org/journals/journal-of-pharmacy-pharmaceutical-sciences/articles/10.3389/jpps.2025.14721/pdf","source":{"id":"https://openalex.org/S166796225","display_name":"Journal of Pharmacy & Pharmaceutical Sciences","issn_l":"1482-1826","issn":["1482-1826"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","jufo-1","ki-jl-1","medline","norway-1","poland-70","russia-white-list-2"],"host_organization":"https://openalex.org/P4310313003","host_organization_name":"Canadian Society for Pharmaceutical Sciences","host_organization_lineage":["https://openalex.org/P4310313003"],"host_organization_lineage_names":["Canadian Society for Pharmaceutical Sciences"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Pharmacy & Pharmaceutical Sciences","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","doaj","pubmed"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://www.frontierspartnerships.org/journals/journal-of-pharmacy-pharmaceutical-sciences/articles/10.3389/jpps.2025.14721/pdf","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5043905754","display_name":"Alfredo Garc\u00eda\u2010Arieta","orcid":"https://orcid.org/0000-0002-9702-6973","observed_orcids":["https://orcid.org/0000-0002-9702-6973"]},"institutions":[{"id":"https://openalex.org/I4210105654","display_name":"World Health Organization","ror":"https://ror.org/01f80g185","country_code":"CH","type":"government","lineage":["https://openalex.org/I4210105654"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"Alfredo Garc\u00eda-Arieta","raw_affiliation_strings":["WHO-Observer, Geneva, Switzerland","WHO-Observer, Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"WHO-Observer, Geneva, Switzerland","institution_ids":["https://openalex.org/I4210105654"]},{"raw_affiliation_string":"WHO-Observer, Switzerland","institution_ids":["https://openalex.org/I4210105654"]}]},{"author_position":"middle","author":{"id":null,"display_name":"Andrew Tam","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1288894424","display_name":"Health Canada","ror":"https://ror.org/05p8nb362","country_code":"CA","type":"government","lineage":["https://openalex.org/I1288894424"]}],"countries":["CA"],"is_corresponding":true,"raw_author_name":"Andrew Tam","raw_affiliation_strings":["Health Canada, Ottawa, ON, Canada","Health Canada, Canada"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Health Canada, Ottawa, ON, Canada","institution_ids":["https://openalex.org/I1288894424"]},{"raw_affiliation_string":"Health Canada, Canada","institution_ids":["https://openalex.org/I1288894424"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5120070560","display_name":"Florencia Tiseyra","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4389425446","display_name":"Administraci\u00f3n Nacional de Medicamentos, Alimentos y Tecnolog\u00eda M\u00e9dica","ror":"https://ror.org/05kxnq107","country_code":"AR","type":"government","lineage":["https://openalex.org/I4389425446"]}],"countries":["AR"],"is_corresponding":false,"raw_author_name":"Florencia Tiseyra","raw_affiliation_strings":["ANMAT, Buenos Aires, Argentina","ANMAT, Argentina"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"ANMAT, Buenos Aires, Argentina","institution_ids":["https://openalex.org/I4389425446"]},{"raw_affiliation_string":"ANMAT, Argentina","institution_ids":["https://openalex.org/I4389425446"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5029401396","display_name":"Eduardo Agostinho Freitas Fernandes","orcid":"https://orcid.org/0009-0006-1115-8577","observed_orcids":["https://orcid.org/0009-0006-1115-8577"]},"institutions":[{"id":"https://openalex.org/I4405271689","display_name":"Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria","ror":"https://ror.org/02vhxmj78","country_code":"BR","type":"government","lineage":["https://openalex.org/I4405271689"]}],"countries":["BR"],"is_corresponding":false,"raw_author_name":"Eduardo Agostinho Freitas Fernandes","raw_affiliation_strings":["ANVISA, Bras\u00edlia, Brazil","ANVISA, Brazil"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"ANVISA, Bras\u00edlia, Brazil","institution_ids":["https://openalex.org/I4405271689"]},{"raw_affiliation_string":"ANVISA, Brazil","institution_ids":["https://openalex.org/I4405271689"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5053344491","display_name":"Kelen Carine Costa Soares","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4405271689","display_name":"Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria","ror":"https://ror.org/02vhxmj78","country_code":"BR","type":"government","lineage":["https://openalex.org/I4405271689"]}],"countries":["BR"],"is_corresponding":false,"raw_author_name":"Kelen Carine Costa Soares","raw_affiliation_strings":["ANVISA, Bras\u00edlia, Brazil","ANVISA, Brazil"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"ANVISA, Bras\u00edlia, Brazil","institution_ids":["https://openalex.org/I4405271689"]},{"raw_affiliation_string":"ANVISA, Brazil","institution_ids":["https://openalex.org/I4405271689"]}]},{"author_position":"middle","author":{"id":null,"display_name":"Raphael Sanches Pereira","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4405271689","display_name":"Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria","ror":"https://ror.org/02vhxmj78","country_code":"BR","type":"government","lineage":["https://openalex.org/I4405271689"]}],"countries":["BR"],"is_corresponding":false,"raw_author_name":"Raphael Sanches Pereira","raw_affiliation_strings":["ANVISA, Bras\u00edlia, Brazil","ANVISA, Brazil"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"ANVISA, Bras\u00edlia, Brazil","institution_ids":["https://openalex.org/I4405271689"]},{"raw_affiliation_string":"ANVISA, Brazil","institution_ids":["https://openalex.org/I4405271689"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5038296470","display_name":"Henrike Potthast","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I123859907","display_name":"Federal Institute for Drugs and Medical Devices","ror":"https://ror.org/05ex5vz81","country_code":"DE","type":"government","lineage":["https://openalex.org/I123859907"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Henrike Potthast","raw_affiliation_strings":["BfArM, Bonn, Germany","BfArM, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"BfArM, Bonn, Germany","institution_ids":["https://openalex.org/I123859907"]},{"raw_affiliation_string":"BfArM, Germany","institution_ids":["https://openalex.org/I123859907"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5021602998","display_name":"Katalina Mettke","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I123859907","display_name":"Federal Institute for Drugs and Medical Devices","ror":"https://ror.org/05ex5vz81","country_code":"DE","type":"government","lineage":["https://openalex.org/I123859907"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Katalina Mettke","raw_affiliation_strings":["BfArM, Bonn, Germany","BfArM, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"BfArM, Bonn, Germany","institution_ids":["https://openalex.org/I123859907"]},{"raw_affiliation_string":"BfArM, Germany","institution_ids":["https://openalex.org/I123859907"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5109941311","display_name":"Ya\u2010Wen Chang","orcid":"https://orcid.org/0009-0002-6388-8388","observed_orcids":["https://orcid.org/0009-0002-6388-8388"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Ya-Wen Chang","raw_affiliation_strings":["CDE, Taipei, Taiwan","CDE, Taiwan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"CDE, Taipei, Taiwan","institution_ids":[]},{"raw_affiliation_string":"CDE, Taiwan","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5042904801","display_name":"Li-Feng Hsu","orcid":"https://orcid.org/0000-0002-6268-3500","observed_orcids":["https://orcid.org/0000-0002-6268-3500"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Li-Feng Hsu","raw_affiliation_strings":["CDE, Taipei, Taiwan","CDE, Taiwan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"CDE, Taipei, Taiwan","institution_ids":[]},{"raw_affiliation_string":"CDE, Taiwan","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5023674914","display_name":"Yu\u2010Lin Su","orcid":"https://orcid.org/0000-0002-8284-5845","observed_orcids":["https://orcid.org/0000-0002-8284-5845"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Yu-Lin Su","raw_affiliation_strings":["CDE, Taipei, Taiwan","CDE, Taiwan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"CDE, Taipei, Taiwan","institution_ids":[]},{"raw_affiliation_string":"CDE, Taiwan","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5051272122","display_name":"Zulema Rodr\u00edguez Mart\u00ednez","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Zulema Rodr\u00edguez Mart\u00ednez","raw_affiliation_strings":["COFEPRIS, M\u00e9xico, Mexico","COFEPRIS, Mexico"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"COFEPRIS, M\u00e9xico, Mexico","institution_ids":[]},{"raw_affiliation_string":"COFEPRIS, Mexico","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5065649375","display_name":"Milly Divinsky","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Milly Divinsky","raw_affiliation_strings":["MOH, Jerusalem, Israel","MOH, Israel"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"MOH, Jerusalem, Israel","institution_ids":[]},{"raw_affiliation_string":"MOH, Israel","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5004817670","display_name":"Kevin V. Blake","orcid":"https://orcid.org/0000-0001-7165-4579","observed_orcids":["https://orcid.org/0000-0001-7165-4579"]},"institutions":[{"id":"https://openalex.org/I1297934274","display_name":"European Medicines Agency","ror":"https://ror.org/01z0wsw92","country_code":"NL","type":"government","lineage":["https://openalex.org/I1297934274","https://openalex.org/I1320481043"]}],"countries":["NL"],"is_corresponding":false,"raw_author_name":"Kevin Blake","raw_affiliation_strings":["EC/EMA, Amsterdam, Netherlands","EC/EMA, Netherlands"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"EC/EMA, Amsterdam, Netherlands","institution_ids":["https://openalex.org/I1297934274"]},{"raw_affiliation_string":"EC/EMA, Netherlands","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5021773494","display_name":"April C. Braddy","orcid":"https://orcid.org/0009-0003-5022-036X","observed_orcids":["https://orcid.org/0009-0003-5022-036X"]},"institutions":[{"id":"https://openalex.org/I1320320070","display_name":"United States Food and Drug Administration","ror":"https://ror.org/034xvzb47","country_code":"US","type":"government","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"April C. Braddy","raw_affiliation_strings":["FDA, Silver Spring, MD, United States","FDA, United States"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"FDA, Silver Spring, MD, United States","institution_ids":["https://openalex.org/I1320320070"]},{"raw_affiliation_string":"FDA, United States","institution_ids":["https://openalex.org/I1320320070"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5052182804","display_name":"Clare Rodrigues","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I2799333108","display_name":"Health Sciences Authority","ror":"https://ror.org/02ybkn114","country_code":"SG","type":"government","lineage":["https://openalex.org/I1291357265","https://openalex.org/I2799333108"]}],"countries":["SG"],"is_corresponding":false,"raw_author_name":"Clare Rodrigues","raw_affiliation_strings":["HSA, Singapore, Singapore","HSA, Singapore"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"HSA, Singapore, Singapore","institution_ids":["https://openalex.org/I2799333108"]},{"raw_affiliation_string":"HSA, Singapore","institution_ids":["https://openalex.org/I2799333108"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5120070558","display_name":"Tiong Toh","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I2799333108","display_name":"Health Sciences Authority","ror":"https://ror.org/02ybkn114","country_code":"SG","type":"government","lineage":["https://openalex.org/I1291357265","https://openalex.org/I2799333108"]}],"countries":["SG"],"is_corresponding":false,"raw_author_name":"Tiong Toh","raw_affiliation_strings":["HSA, Singapore, Singapore","HSA, Singapore"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"HSA, Singapore, Singapore","institution_ids":["https://openalex.org/I2799333108"]},{"raw_affiliation_string":"HSA, Singapore","institution_ids":["https://openalex.org/I2799333108"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5088857666","display_name":"Erwin Guzm\u00e1n Aurela","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Erwin Guzman Aurela","raw_affiliation_strings":["INVIMA, Bogota, Colombia","INVIMA, Colombia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"INVIMA, Bogota, Colombia","institution_ids":[]},{"raw_affiliation_string":"INVIMA, Colombia","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5055664402","display_name":"Liliana Carolina Ar\u00e9valo Gonz\u00e1lez","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Liliana Carolina Ar\u00e9valo Gonz\u00e1lez","raw_affiliation_strings":["INVIMA, Bogota, Colombia","INVIMA, Colombia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"INVIMA, Bogota, Colombia","institution_ids":[]},{"raw_affiliation_string":"INVIMA, Colombia","institution_ids":[]}]},{"author_position":"middle","author":{"id":null,"display_name":"Ben Jones","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Ben Jones","raw_affiliation_strings":["Medsafe, Wellington, New Zealand","Medsafe, New Zealand"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Medsafe, Wellington, New Zealand","institution_ids":[]},{"raw_affiliation_string":"Medsafe, New Zealand","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5100411754","display_name":"Sohee Kim","orcid":"https://orcid.org/0000-0002-4926-8978","observed_orcids":["https://orcid.org/0000-0002-4926-8978"]},"institutions":[{"id":"https://openalex.org/I118406505","display_name":"Ministry of Food and Drug Safety","ror":"https://ror.org/01f7dp456","country_code":"KR","type":"government","lineage":["https://openalex.org/I118406505"]}],"countries":["KR"],"is_corresponding":false,"raw_author_name":"So Hee Kim","raw_affiliation_strings":["MFDS, Cheongju-si, Republic of Korea","MFDS, Republic of Korea"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"MFDS, Cheongju-si, Republic of Korea","institution_ids":["https://openalex.org/I118406505"]},{"raw_affiliation_string":"MFDS, Republic of Korea","institution_ids":["https://openalex.org/I118406505"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5031663403","display_name":"Choongyul Ahn","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I118406505","display_name":"Ministry of Food and Drug Safety","ror":"https://ror.org/01f7dp456","country_code":"KR","type":"government","lineage":["https://openalex.org/I118406505"]}],"countries":["KR"],"is_corresponding":false,"raw_author_name":"Choongyul Ahn","raw_affiliation_strings":["MFDS, Cheongju-si, Republic of Korea","MFDS, Republic of Korea"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"MFDS, Cheongju-si, Republic of Korea","institution_ids":["https://openalex.org/I118406505"]},{"raw_affiliation_string":"MFDS, Republic of Korea","institution_ids":["https://openalex.org/I118406505"]}]},{"author_position":"middle","author":{"id":null,"display_name":"Eunju Yun","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I118406505","display_name":"Ministry of Food and Drug Safety","ror":"https://ror.org/01f7dp456","country_code":"KR","type":"government","lineage":["https://openalex.org/I118406505"]}],"countries":["KR"],"is_corresponding":false,"raw_author_name":"Eunju Yun","raw_affiliation_strings":["MFDS, Cheongju-si, Republic of Korea","MFDS, Republic of Korea"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"MFDS, Cheongju-si, Republic of Korea","institution_ids":["https://openalex.org/I118406505"]},{"raw_affiliation_string":"MFDS, Republic of Korea","institution_ids":["https://openalex.org/I118406505"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5030909721","display_name":"Ryosuke Kuribayashi","orcid":"https://orcid.org/0000-0002-6778-7114","observed_orcids":["https://orcid.org/0000-0002-6778-7114"]},"institutions":[{"id":"https://openalex.org/I91962293","display_name":"Pharmaceuticals and Medical Devices Agency","ror":"https://ror.org/03mpkb302","country_code":"JP","type":"government","lineage":["https://openalex.org/I91962293"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"Ryosuke Kuribayashi","raw_affiliation_strings":["PMDA, Tokyo, Japan","PMDA, Japan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"PMDA, Tokyo, Japan","institution_ids":["https://openalex.org/I91962293"]},{"raw_affiliation_string":"PMDA, Japan","institution_ids":["https://openalex.org/I91962293"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5074471974","display_name":"Kohei Shimojo","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I91962293","display_name":"Pharmaceuticals and Medical Devices Agency","ror":"https://ror.org/03mpkb302","country_code":"JP","type":"government","lineage":["https://openalex.org/I91962293"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"Kohei Shimojo","raw_affiliation_strings":["PMDA, Tokyo, Japan","PMDA, Japan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"PMDA, Tokyo, Japan","institution_ids":["https://openalex.org/I91962293"]},{"raw_affiliation_string":"PMDA, Japan","institution_ids":["https://openalex.org/I91962293"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5083976304","display_name":"Miho Kasuga","orcid":"https://orcid.org/0000-0002-3158-5633","observed_orcids":["https://orcid.org/0000-0002-3158-5633"]},"institutions":[{"id":"https://openalex.org/I91962293","display_name":"Pharmaceuticals and Medical Devices Agency","ror":"https://ror.org/03mpkb302","country_code":"JP","type":"government","lineage":["https://openalex.org/I91962293"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"Miho Kasuga","raw_affiliation_strings":["PMDA, Tokyo, Japan","PMDA, Japan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"PMDA, Tokyo, Japan","institution_ids":["https://openalex.org/I91962293"]},{"raw_affiliation_string":"PMDA, Japan","institution_ids":["https://openalex.org/I91962293"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5120070559","display_name":"Junya Makino","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I91962293","display_name":"Pharmaceuticals and Medical Devices Agency","ror":"https://ror.org/03mpkb302","country_code":"JP","type":"government","lineage":["https://openalex.org/I91962293"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"Junya Makino","raw_affiliation_strings":["PMDA, Tokyo, Japan","PMDA, Japan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"PMDA, Tokyo, Japan","institution_ids":["https://openalex.org/I91962293"]},{"raw_affiliation_string":"PMDA, Japan","institution_ids":["https://openalex.org/I91962293"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5062431087","display_name":"Joel Raffel","orcid":"https://orcid.org/0000-0002-3446-241X","observed_orcids":["https://orcid.org/0000-0002-3446-241X"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Joel Raffel","raw_affiliation_strings":["MHRA, London, United Kingdom","MHRA, United Kingdom"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"MHRA, London, United Kingdom","institution_ids":[]},{"raw_affiliation_string":"MHRA, United Kingdom","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5078219528","display_name":"Joy Van Oudtshoorn","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Joy van Oudtshoorn","raw_affiliation_strings":["SAHPRA, Pretoria, South Africa","SAHPRA, South Africa"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"SAHPRA, Pretoria, South Africa","institution_ids":[]},{"raw_affiliation_string":"SAHPRA, South Africa","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5120070561","display_name":"Philda Tabane","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Philda Tabane","raw_affiliation_strings":["SAHPRA, Pretoria, South Africa","SAHPRA, South Africa"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"SAHPRA, Pretoria, South Africa","institution_ids":[]},{"raw_affiliation_string":"SAHPRA, South Africa","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5015119059","display_name":"Bader R. Alzenaidy","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4405272187","display_name":"Saudi Food and Drug Authority","ror":"https://ror.org/03qdtqk38","country_code":"SA","type":"government","lineage":["https://openalex.org/I4405272187"]}],"countries":["SA"],"is_corresponding":false,"raw_author_name":"Bader Alzenaidy","raw_affiliation_strings":["SFDA, Riyadh, Saudi Arabia","SFDA, Saudi Arabia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"SFDA, Riyadh, Saudi Arabia","institution_ids":["https://openalex.org/I4405272187"]},{"raw_affiliation_string":"SFDA, Saudi Arabia","institution_ids":["https://openalex.org/I4405272187"]}]},{"author_position":"middle","author":{"id":null,"display_name":"Mohammed AlHarbi","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4405272187","display_name":"Saudi Food and Drug Authority","ror":"https://ror.org/03qdtqk38","country_code":"SA","type":"government","lineage":["https://openalex.org/I4405272187"]}],"countries":["SA"],"is_corresponding":false,"raw_author_name":"Mohammed AlHarbi","raw_affiliation_strings":["SFDA, Riyadh, Saudi Arabia","SFDA, Saudi Arabia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"SFDA, Riyadh, Saudi Arabia","institution_ids":["https://openalex.org/I4405272187"]},{"raw_affiliation_string":"SFDA, Saudi Arabia","institution_ids":["https://openalex.org/I4405272187"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5073234441","display_name":"Adel Alharf","orcid":"https://orcid.org/0000-0001-8215-3198","observed_orcids":["https://orcid.org/0000-0001-8215-3198"]},"institutions":[{"id":"https://openalex.org/I4405272187","display_name":"Saudi Food and Drug Authority","ror":"https://ror.org/03qdtqk38","country_code":"SA","type":"government","lineage":["https://openalex.org/I4405272187"]}],"countries":["SA"],"is_corresponding":false,"raw_author_name":"Adel Alharf","raw_affiliation_strings":["SFDA, Riyadh, Saudi Arabia","SFDA, Saudi Arabia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"SFDA, Riyadh, Saudi Arabia","institution_ids":["https://openalex.org/I4405272187"]},{"raw_affiliation_string":"SFDA, Saudi Arabia","institution_ids":["https://openalex.org/I4405272187"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5092524013","display_name":"Albatool A. Binajlan","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4405272187","display_name":"Saudi Food and Drug Authority","ror":"https://ror.org/03qdtqk38","country_code":"SA","type":"government","lineage":["https://openalex.org/I4405272187"]}],"countries":["SA"],"is_corresponding":false,"raw_author_name":"Albatool BinAjlan","raw_affiliation_strings":["SFDA, Riyadh, Saudi Arabia","SFDA, Saudi Arabia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"SFDA, Riyadh, Saudi Arabia","institution_ids":["https://openalex.org/I4405272187"]},{"raw_affiliation_string":"SFDA, Saudi Arabia","institution_ids":["https://openalex.org/I4405272187"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5108345715","display_name":"Chantal Walther","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1325311562","display_name":"Swissmedic","ror":"https://ror.org/03hdjmh87","country_code":"CH","type":"government","lineage":["https://openalex.org/I1325311562"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"Chantal Walther","raw_affiliation_strings":["Swissmedic, Bern, Switzerland","Swissmedic, Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Swissmedic, Bern, Switzerland","institution_ids":["https://openalex.org/I1325311562"]},{"raw_affiliation_string":"Swissmedic, Switzerland","institution_ids":["https://openalex.org/I1325311562"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5066500748","display_name":"Matthias S. Roost","orcid":"https://orcid.org/0009-0008-9227-8873","observed_orcids":["https://orcid.org/0009-0008-9227-8873"]},"institutions":[{"id":"https://openalex.org/I1325311562","display_name":"Swissmedic","ror":"https://ror.org/03hdjmh87","country_code":"CH","type":"government","lineage":["https://openalex.org/I1325311562"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"Matthias S. Roost","raw_affiliation_strings":["Swissmedic, Bern, Switzerland","Swissmedic, Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Swissmedic, Bern, Switzerland","institution_ids":["https://openalex.org/I1325311562"]},{"raw_affiliation_string":"Swissmedic, Switzerland","institution_ids":["https://openalex.org/I1325311562"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5036651920","display_name":"Christopher Crane","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Christopher Crane","raw_affiliation_strings":["TGA, Canberra, ACT, Australia","TGA, Australia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"TGA, Canberra, ACT, Australia","institution_ids":[]},{"raw_affiliation_string":"TGA, Australia","institution_ids":[]}]},{"author_position":"last","author":{"id":null,"display_name":"Kitty Lee","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Kitty Lee","raw_affiliation_strings":["TGA, Canberra, ACT, Australia","TGA, Australia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"TGA, Canberra, ACT, Australia","institution_ids":[]},{"raw_affiliation_string":"TGA, Australia","institution_ids":[]}]}],"institutions":[],"countries_distinct_count":11,"institutions_distinct_count":12,"corresponding_author_ids":[],"corresponding_institution_ids":["https://openalex.org/I1288894424"],"apc_list":{"value":2200,"currency":"USD","value_usd":2200},"apc_paid":{"value":2200,"currency":"USD","value_usd":2200},"fwci":0.6545,"has_fulltext":true,"cited_by_count":1,"citation_normalized_percentile":{"value":0.6638963,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":91,"max":95},"biblio":{"volume":"28","issue":null,"first_page":"14721","last_page":"14721"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11792","display_name":"Pharmaceutical Economics and Policy","score":0.6718999743461609,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},"topics":[{"id":"https://openalex.org/T11792","display_name":"Pharmaceutical Economics and Policy","score":0.6718999743461609,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.10819999873638153,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T12547","display_name":"Pharmaceutical studies and practices","score":0.10599999874830246,"subfield":{"id":"https://openalex.org/subfields/2735","display_name":"Pediatrics, Perinatology and Child Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/biowaiver","display_name":"biowaiver","score":0.824999988079071},{"id":"https://openalex.org/keywords/generic-drugs","display_name":"generic drugs","score":0.7070000171661377},{"id":"https://openalex.org/keywords/regulatory-recommendations","display_name":"regulatory recommendations","score":0.6489999890327454},{"id":"https://openalex.org/keywords/topical-dosage-forms","display_name":"topical dosage forms","score":0.8019999861717224},{"id":"https://openalex.org/keywords/eye-drops","display_name":"eye drops","score":0.8360000252723694},{"id":"https://openalex.org/keywords/enema","display_name":"enema","score":0.7789999842643738},{"id":"https://openalex.org/keywords/vaginal-suppositories","display_name":"vaginal suppositories","score":0.8830000162124634},{"id":"https://openalex.org/keywords/biopharmaceutics-classification-system","display_name":"Biopharmaceutics Classification System","score":0.9449999928474426},{"id":"https://openalex.org/keywords/regulatory-convergence","display_name":"regulatory convergence","score":0.7929999828338623}],"concepts":[{"id":"https://openalex.org/C42404028","wikidata":"https://www.wikidata.org/wiki/Q864940","display_name":"Bioequivalence","level":3,"score":0.9437999725341797},{"id":"https://openalex.org/C77281830","wikidata":"https://www.wikidata.org/wiki/Q718608","display_name":"Dosage form","level":2,"score":0.7239000201225281},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.5044999718666077},{"id":"https://openalex.org/C2910701995","wikidata":"https://www.wikidata.org/wiki/Q679692","display_name":"Biopharmaceutics","level":5,"score":0.4478999972343445},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.4361000061035156},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.3790000081062317},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.3702000081539154},{"id":"https://openalex.org/C2779652045","wikidata":"https://www.wikidata.org/wiki/Q507443","display_name":"Pharmaceutical industry","level":2,"score":0.36970001459121704},{"id":"https://openalex.org/C2984430287","wikidata":"https://www.wikidata.org/wiki/Q186249","display_name":"Pharmaceutical technology","level":2,"score":0.3537999987602234},{"id":"https://openalex.org/C2781430271","wikidata":"https://www.wikidata.org/wiki/Q278760","display_name":"Biopharmaceutics Classification System","level":3,"score":0.33489999175071716},{"id":"https://openalex.org/C45904493","wikidata":"https://www.wikidata.org/wiki/Q912807","display_name":"Active ingredient","level":2,"score":0.3199000060558319},{"id":"https://openalex.org/C2776396487","wikidata":"https://www.wikidata.org/wiki/Q506319","display_name":"Generic drug","level":3,"score":0.26649999618530273},{"id":"https://openalex.org/C162118730","wikidata":"https://www.wikidata.org/wiki/Q1128453","display_name":"Actuarial science","level":1,"score":0.2639000117778778},{"id":"https://openalex.org/C56666940","wikidata":"https://www.wikidata.org/wiki/Q788790","display_name":"Documentation","level":2,"score":0.2581999897956848},{"id":"https://openalex.org/C2781047461","wikidata":"https://www.wikidata.org/wiki/Q679692","display_name":"Biopharmaceutical","level":2,"score":0.25380000472068787}],"mesh":[{"descriptor_ui":"D004304","descriptor_name":"Dosage Forms","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011795","descriptor_name":"Surveys and Questionnaires","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D013810","descriptor_name":"Therapeutic Equivalency","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016568","descriptor_name":"Drugs, Generic","qualifier_ui":"Q000008","qualifier_name":"administration & dosage","is_major_topic":true},{"descriptor_ui":"D016568","descriptor_name":"Drugs, Generic","qualifier_ui":"Q000493","qualifier_name":"pharmacokinetics","is_major_topic":true},{"descriptor_ui":"D017408","descriptor_name":"Guidelines as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":5,"locations":[{"id":"doi:10.3389/jpps.2025.14721","doi":"https://doi.org/10.3389/jpps.2025.14721","is_oa":true,"landing_page_url":"https://doi.org/10.3389/jpps.2025.14721","pdf_url":"https://www.frontierspartnerships.org/journals/journal-of-pharmacy-pharmaceutical-sciences/articles/10.3389/jpps.2025.14721/pdf","source":{"id":"https://openalex.org/S166796225","display_name":"Journal of Pharmacy & Pharmaceutical Sciences","issn_l":"1482-1826","issn":["1482-1826"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","jufo-1","ki-jl-1","medline","norway-1","poland-70","russia-white-list-2"],"host_organization":"https://openalex.org/P4310313003","host_organization_name":"Canadian Society for Pharmaceutical Sciences","host_organization_lineage":["https://openalex.org/P4310313003"],"host_organization_lineage_names":["Canadian Society for Pharmaceutical Sciences"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Pharmacy & Pharmaceutical Sciences","raw_type":"journal-article"},{"id":"pmh:oai:europepmc.org:11389426","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/12580124","pdf_url":null,"source":{"id":"https://openalex.org/S4306400806","display_name":"Europe PMC (PubMed Central)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1303153112","host_organization_name":"European Bioinformatics Institute","host_organization_lineage":["https://openalex.org/I1303153112"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":null,"raw_type":"Text"},{"id":"pmid:41189551","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/41189551","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques","raw_type":"Journal Article"},{"id":"pmh:oai:pubmedcentral.nih.gov:12580124","doi":null,"is_oa":true,"landing_page_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12580124/","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"J Pharm Pharm Sci","raw_type":"Text"},{"id":"pmh:oai:doaj.org/article:13e23d65daf64c7c981b0f7df31c1e3e","doi":null,"is_oa":true,"landing_page_url":"https://doaj.org/article/13e23d65daf64c7c981b0f7df31c1e3e","pdf_url":null,"source":{"id":"https://openalex.org/S4306401280","display_name":"DOAJ (DOAJ: Directory of Open Access Journals)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by-sa","license_id":"https://openalex.org/licenses/cc-by-sa","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Journal of Pharmacy & Pharmaceutical Sciences, Vol 28 (2025)","raw_type":"article"}],"best_oa_location":{"id":"doi:10.3389/jpps.2025.14721","doi":"https://doi.org/10.3389/jpps.2025.14721","is_oa":true,"landing_page_url":"https://doi.org/10.3389/jpps.2025.14721","pdf_url":"https://www.frontierspartnerships.org/journals/journal-of-pharmacy-pharmaceutical-sciences/articles/10.3389/jpps.2025.14721/pdf","source":{"id":"https://openalex.org/S166796225","display_name":"Journal of Pharmacy & Pharmaceutical Sciences","issn_l":"1482-1826","issn":["1482-1826"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","jufo-1","ki-jl-1","medline","norway-1","poland-70","russia-white-list-2"],"host_organization":"https://openalex.org/P4310313003","host_organization_name":"Canadian Society for Pharmaceutical Sciences","host_organization_lineage":["https://openalex.org/P4310313003"],"host_organization_lineage_names":["Canadian Society for Pharmaceutical Sciences"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Pharmacy & Pharmaceutical Sciences","raw_type":"journal-article"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","score":0.5683000087738037,"display_name":"Good health and well-being"}],"study_designs":[],"awards":[],"funders":[{"id":"https://openalex.org/F4320307856","display_name":"World Health Organization","ror":"https://ror.org/01f80g185"}],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4415364752.pdf","grobid_xml":"https://content.openalex.org/works/W4415364752.grobid-xml"},"referenced_works_count":4,"referenced_works":["https://openalex.org/W2785965975","https://openalex.org/W2978745607","https://openalex.org/W3138344390","https://openalex.org/W4206953775"],"related_works":["https://openalex.org/W3138344390","https://openalex.org/W4387709776","https://openalex.org/W3210648442","https://openalex.org/W2785965975","https://openalex.org/W7160963479","https://openalex.org/W2884064719","https://openalex.org/W4385458940","https://openalex.org/W3031486576","https://openalex.org/W2328752130","https://openalex.org/W2522597785"],"abstract_inverted_index":{"bioequivalence":[0],"study.":[1],"A":[2,87],"biowaiver":[3,38],"may":[4],"be":[5,159],"granted":[6],"not":[7,130],"only":[8],"based":[9,23],"on":[10,24],"the":[11,31,37,70,73,81,90,93,104,111,119,140,145],"Biopharmaceutics":[12],"Classifications":[13],"System":[14],"(BCS)":[15],"but":[16],"also":[17],"for":[18,40,77,153,161,169],"many":[19],"immediate-release":[20],"dosage":[21,64,105,155],"forms":[22,65,106,156],"pre-defined":[25],"criteria.":[26],"The":[27],"current":[28],"paper":[29],"summarises":[30],"results":[32,91],"from":[33,92],"a":[34,99,122],"survey":[35,94],"of":[36,72,80,89,118],"requirements":[39],"cutaneous/topical":[41],"products":[42,168],"(topical":[43],"solutions,":[44],"gels,":[45],"suspensions,":[46,55],"ointments,":[47],"and":[48,51,54,59,61,66,157],"creams),":[49],"ear/otic":[50],"ophthalmic":[52],"solutions":[53],"enemas":[56],"in":[57],"solution":[58],"suspension,":[60],"vaginal":[62],"solid":[63],"suppositories":[67],"defined":[68],"by":[69,116,172],"participants":[71,120,128],"Bioequivalence":[74],"Working":[75],"Group":[76],"Generics":[78],"(BEWGG)":[79],"International":[82],"Pharmaceutical":[83],"Regulators":[84],"Programme":[85],"(IPRP).":[86],"review":[88],"indicates":[95],"that":[96,126],"there":[97],"is":[98,144],"trend":[100],"towards":[101,148],"convergence":[102,150],"when":[103],"are":[107],"less":[108],"complex;":[109],"however,":[110],"most":[112,127],"common":[113],"approach":[114,124],"used":[115],"each":[117],"was":[121],"case-by-case":[123],"given":[125],"do":[129],"have":[131],"well-defined":[132],"guidelines":[133],"to":[134],"support":[135],"all":[136],"possible":[137],"scenarios.":[138],"Notwithstanding":[139],"differences,":[141],"disseminating":[142],"information":[143],"first":[146],"step":[147],"regulatory":[149],"regarding":[151],"biowaivers":[152],"certain":[154],"will":[158],"useful":[160],"pharmaceutical":[162],"companies":[163],"currently":[164],"developing":[165],"generic":[166],"medicinal":[167],"countries":[170],"represented":[171],"IPRP":[173],"participants.":[174]},"counts_by_year":[{"year":2026,"cited_by_count":1}],"updated_date":"2026-11-10T11:39:43.021295","created_date":"2025-10-21T00:00:00"}