Conjunction of semi-mechanistic in vitro-in vivo modeling and population pharmacokinetics as a tool for virtual bioequivalence analysis - a case study for a BCS class II drug

Author:

Danielak DorotaORCID,Paszkowska JadwigaORCID,Staniszewska MarcelaORCID,Garbacz GrzegorzORCID,Terlecka Anna,Kubiak Bartłomiej,Romański MichałORCID

Publisher

Elsevier BV

Subject

Pharmaceutical Science,General Medicine,Biotechnology

Reference42 articles.

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2. EMA. Investigation of bioequivalence - Scientific guideline. Eur Med Agency 2018. https://www.ema.europa.eu/en/investigation-bioequivalence-scientific-guideline (accessed December 21, 2022).

3. Research C for DE and. Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application. US Food Drug Adm 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioequivalence-studies-pharmacokinetic-endpoints-drugs-submitted-under-abbreviated-new-drug (accessed December 21, 2022).

4. The Use of Physiologically Based Pharmacokinetic Analyses-in Biopharmaceutics Applications -Regulatory and Industry Perspectives;Anand;Pharm. Res.,2022

5. In Silico Modeling and Simulation to Guide Bioequivalence Testing for Oral Drugs in a Virtual Population;Zhang;Clin. Pharmacokinet.,2021

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