FDA Bioequivalence Standards:
This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies,...
Gespeichert in:
| Format: | Elektronisch E-Book |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
New York, NY [u.a.]
Springer
2014
|
| Schriftenreihe: | AAPS Advances in the Pharmaceutical Sciences Series
13 |
| Schlagworte: | |
| Online-Zugang: | TUM01 UBT01 Volltext |
| Zusammenfassung: | This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation, and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products, and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies, and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards |
| Beschreibung: | 1 Online-Ressource |
| ISBN: | 9781493912520 |
| DOI: | 10.1007/978-1-4939-1252-0 |
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| spelling | FDA Bioequivalence Standards Lawrence X. Yu ; Bing V. Li, ed. New York, NY [u.a.] Springer 2014 1 Online-Ressource txt rdacontent c rdamedia cr rdacarrier AAPS Advances in the Pharmaceutical Sciences Series 13 This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation, and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products, and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies, and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards Medizin Medicine Pharmaceutical technology Yu, Lawrence X. Sonstige oth Li, Bing V. Sonstige oth Erscheint auch als Druckausgabe 978-1-4939-1251-3 AAPS Advances in the Pharmaceutical Sciences Series 13 (DE-604)BV041360401 13 https://doi.org/10.1007/978-1-4939-1252-0 Verlag Volltext |
| spellingShingle | FDA Bioequivalence Standards AAPS Advances in the Pharmaceutical Sciences Series Medizin Medicine Pharmaceutical technology |
| title | FDA Bioequivalence Standards |
| title_auth | FDA Bioequivalence Standards |
| title_exact_search | FDA Bioequivalence Standards |
| title_full | FDA Bioequivalence Standards Lawrence X. Yu ; Bing V. Li, ed. |
| title_fullStr | FDA Bioequivalence Standards Lawrence X. Yu ; Bing V. Li, ed. |
| title_full_unstemmed | FDA Bioequivalence Standards Lawrence X. Yu ; Bing V. Li, ed. |
| title_short | FDA Bioequivalence Standards |
| title_sort | fda bioequivalence standards |
| topic | Medizin Medicine Pharmaceutical technology |
| topic_facet | Medizin Medicine Pharmaceutical technology |
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