Simplified Model-Dependent and Model-Independent Approaches for Dissolution Profile Comparison for Oral Products: Regulatory Perspective for Generic Product Development-Reference-Cited by-同舟云学术

Simplified Model-Dependent and Model-Independent Approaches for Dissolution Profile Comparison for Oral Products: Regulatory Perspective for Generic Product Development

Published:2022-01 Issue:1 Volume:23 Page:
ISSN:1530-9932
Container-title:AAPS PharmSciTech
language:en
Short-container-title:AAPS PharmSciTech

Author:

Kollipara Sivacharan^ORCID,Boddu Rajkumar^ORCID,Ahmed Tausif^ORCID,Chachad Siddharth

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science,Agronomy and Crop Science,Ecology,Aquatic Science,General Medicine,Ecology, Evolution, Behavior and Systematics

Link

https://link.springer.com/content/pdf/10.1208/s12249-021-02203-7.pdf

Reference23 articles.

1. USFDA BCS Based biowaiver guidance. 2021. https://www.fda.gov/media/148472/download#:~:text=The%20BCS%2Dbased%20biowaiver%20is,based%20biowaiver%20in%20this%20guidance. Accessed 10 Oct 2021.

2. USFDA IVIVC guidance. 1997. https://www.fda.gov/media/70939/download. .

3. USFDA Dissolution guidance. 1997. https://www.fda.gov/media/70936/download. .

4. USFDA SUPAC MR guidance. 1997. https://www.fda.gov/media/70956/download. Accessed 10 Oct 2021.

5. EMA Bioequivalence guidance. 2010. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-bioequivalence-rev1_en.pdf. Accessed 10 Oct 2021.

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