DISSOLUTION PROFILE SIMILARITY ANALYSES—STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS

Author:

Hoffelder ThomasORCID,Leblond David,Van Alstine Leslie,Diaz Dorys Argelia,Suarez-Sharp Sandra,Witkowski Krista,Altan Stan,Reynolds James,Bergeron Zachary,Lief Kevin,Zheng Yanbing,Abend Andreas

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference46 articles.

1. National Health Surveillance Agency of Brazil (ANVISA). Resolution RDC No 31. Provides information about the studies of pharmaceutical equivalence and comparative dissolution profile. 2010.

2. European Medicines Agency (EMA). Committee for medicinal products for human use. Guideline on the Investigation of Bioequivalence CPMP/EWP/QWP/1401/98 Rev.1/Corr**. 2010.

3. U.S. Department of Health and Human Services - Food and Drug Administration, CDER (FDA). Guidance for Industry: Immediate Release Solid Oral Dosage Forms: Scale-Up and Post approval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation. 1995.

4. U.S. Department of Health and Human Services—Food and Drug Administration, CDER (FDA). Guidance for Industry - Dissolution Testing of Immediate Release Solid Oral Dosage Forms. 1997.

5. U.S. Department of Health and Human Services—Food and Drug Administration, CDER (FDA). Guidance for industry— Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances. 2018.

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