Biowaiver based on biopharmaceutics classification system: Considerations and requirements
Biowaiver allows for the waiver of bioequivalence studies for regulatory approval of certain drug products with saving of time, and money. Before approval of the application for biowaivers, studies based on the Biopharmaceutical Classification System (BCS) are required to satisfy regulators in the U...
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| Format: | Article |
| Language: | English |
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Elsevier
2024-12-01
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| Series: | Pharmaceutical Science Advances |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2773216923000181 |
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| author | Pratik R. Dhake Smita T. Kumbhar Vinod L. Gaikwad |
| author_facet | Pratik R. Dhake Smita T. Kumbhar Vinod L. Gaikwad |
| author_sort | Pratik R. Dhake |
| collection | DOAJ |
| description | Biowaiver allows for the waiver of bioequivalence studies for regulatory approval of certain drug products with saving of time, and money. Before approval of the application for biowaivers, studies based on the Biopharmaceutical Classification System (BCS) are required to satisfy regulators in the US, Europe, and other developing markets. Only pharmaceutical products that meet the regulatory requirements for solubility, diffusion, and permeability will be granted a biowaiver. Due to high solubility and considerable permeability, BCS class I and class III drugs are highly preferred for biowaiver by regulatory agencies. The World Health Organization recently expanded the scope of the biowaiver acceptance by considering all BCS classes. These techniques can cut down on time and money spent on ineffective bioequivalence studies. In the present article, an attempt has been made to cover the prerequisites and guidelines for biowaiver approval of a generic product, a topical system, oral films, and BCS class II and IV drugs. |
| format | Article |
| id | doaj-art-e9f2ea8fcea54ad69a125770d0e823bb |
| institution | Kabale University |
| issn | 2773-2169 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Pharmaceutical Science Advances |
| spelling | doaj-art-e9f2ea8fcea54ad69a125770d0e823bb2024-12-07T08:35:10ZengElsevierPharmaceutical Science Advances2773-21692024-12-012100020Biowaiver based on biopharmaceutics classification system: Considerations and requirementsPratik R. Dhake0Smita T. Kumbhar1Vinod L. Gaikwad2Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Hajipur, 844 102, Bihar, IndiaDepartment of Pharmaceutical Chemistry, DSTS Mandal's College of Pharmacy, Solapur- 413 004, Maharashtra, IndiaDepartment of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Hajipur, 844 102, Bihar, India; Corresponding author.Biowaiver allows for the waiver of bioequivalence studies for regulatory approval of certain drug products with saving of time, and money. Before approval of the application for biowaivers, studies based on the Biopharmaceutical Classification System (BCS) are required to satisfy regulators in the US, Europe, and other developing markets. Only pharmaceutical products that meet the regulatory requirements for solubility, diffusion, and permeability will be granted a biowaiver. Due to high solubility and considerable permeability, BCS class I and class III drugs are highly preferred for biowaiver by regulatory agencies. The World Health Organization recently expanded the scope of the biowaiver acceptance by considering all BCS classes. These techniques can cut down on time and money spent on ineffective bioequivalence studies. In the present article, an attempt has been made to cover the prerequisites and guidelines for biowaiver approval of a generic product, a topical system, oral films, and BCS class II and IV drugs.http://www.sciencedirect.com/science/article/pii/S2773216923000181BiowaiverBiopharmaceutics classification systemBioequivalentSolubilityPermeabilityGenerics |
| spellingShingle | Pratik R. Dhake Smita T. Kumbhar Vinod L. Gaikwad Biowaiver based on biopharmaceutics classification system: Considerations and requirements Pharmaceutical Science Advances Biowaiver Biopharmaceutics classification system Bioequivalent Solubility Permeability Generics |
| title | Biowaiver based on biopharmaceutics classification system: Considerations and requirements |
| title_full | Biowaiver based on biopharmaceutics classification system: Considerations and requirements |
| title_fullStr | Biowaiver based on biopharmaceutics classification system: Considerations and requirements |
| title_full_unstemmed | Biowaiver based on biopharmaceutics classification system: Considerations and requirements |
| title_short | Biowaiver based on biopharmaceutics classification system: Considerations and requirements |
| title_sort | biowaiver based on biopharmaceutics classification system considerations and requirements |
| topic | Biowaiver Biopharmaceutics classification system Bioequivalent Solubility Permeability Generics |
| url | http://www.sciencedirect.com/science/article/pii/S2773216923000181 |
| work_keys_str_mv | AT pratikrdhake biowaiverbasedonbiopharmaceuticsclassificationsystemconsiderationsandrequirements AT smitatkumbhar biowaiverbasedonbiopharmaceuticsclassificationsystemconsiderationsandrequirements AT vinodlgaikwad biowaiverbasedonbiopharmaceuticsclassificationsystemconsiderationsandrequirements |