In vitro and In silico biopharmaceutic regulatory guidelines for generic bioequivalence for oral products: Comparison among various regulatory agencies-Reference-Cited by-同舟云学术

In vitro and In silico biopharmaceutic regulatory guidelines for generic bioequivalence for oral products: Comparison among various regulatory agencies

Published:2021-06-06 Issue:7 Volume:42 Page:297-318
ISSN:0142-2782
Container-title:Biopharmaceutics & Drug Disposition
language:en
Short-container-title:Biopharm Drug Dispos

Author:

Kollipara Sivacharan¹^ORCID,Ahmed Tausif¹^ORCID,Bhattiprolu Adithya Karthik¹,Chachad Siddharth¹

Affiliation:

1. Biopharmaceutics Group Global Clinical Management Dr. Reddy’s Laboratories Ltd. Integrated Product Development Organization (IPDO) Hyderabad Telangana India

Publisher

Wiley

Subject

Pharmacology (medical),Pharmaceutical Science,Pharmacology,General Medicine

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/bdd.2292

Reference54 articles.

1. ANVISA. (2010). Realization of Pharmaceutical Equivalence Studies and Comparative Dissolution Profile. RDC 31.

2. ANVISA. (2011a). NORMATIVE INSTRUCTION – NI No. 4 FROM AUGUST 3RD List of candidates for bioexemption based on biopharmaceutics classification system (BCS)

3. ANVISA. (2011b). Provides for the guide for exemption and replacement in studies in relative bioavailability/bioequivalence and makes other arrangements. RDC 37 Aug.https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?jornal=1&pagina=117&data=05/08/2011

4. ASEAN. (2015). ASEAN guideline for the conduct of bioequivalence studies.https://asean.org/wp‐content/uploads/2012/10/BE_Guideline_FinalMarch2015_endorsed_22PPWG.pdf

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