A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH

Author:

Zhu Hao1,Chen Xiaomei1,Ahmed Mariam1,Wang Yaning1,Liu Qi1,Uppoor Ramana S.1,Kuemmel Colleen1,Mehta Mehul1

Affiliation:

1. Office of Clinical Pharmacology Office of Translational Science, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Funder

U.S. Food and Drug Administration

U.S. Department of Energy

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Reference31 articles.

1. US Food and Drug Administration 21 CFR320.1.Bioavailability and bioequivalence requirements [online]. Accessed May 3 2017.

2. US Food and Drug Administration.Guidance for industry: bioequivalence studies with pharmacokinetic endpoints for drugs submitted under an ANDA. [online] . Accessed August 2 2017.

3. US Food and Drug Administration.Guidance for industry: bioavailability and bioequivalence studies submitted in NDAs or INDs – general considerations. [online] . Accessed August 2 2017.

4. Frequency analyses of gastric pH in control and gastro-oesophageal reflux disease subjects treated with a proton-pump inhibitor

5. pH-Dependent Drug–Drug Interactions for Weak Base Drugs: Potential Implications for New Drug Development

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