Use of Partial Area Under the Curve in Bioavailability or Bioequivalence Assessments: A Regulatory Perspective-Reference-Cited by-同舟云学术

Use of Partial Area Under the Curve in Bioavailability or Bioequivalence Assessments: A Regulatory Perspective

Published:2021-02-28 Issue:4 Volume:110 Page:880-887
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Fang Lanyan¹,Uppoor Ramana²,Xu Mingjiang¹,Sharan Satish¹,Zhu Hao²,Tampal Nilufer³,Li Bing³,Zhang Lei¹,Lionberger Robert¹,Zhao Liang¹

Affiliation:

1. Office of Research and Standards, Office of Generic Drugs Center for Drug Evaluation and ResearchUS Food and Drug Administration Silver Spring Maryland USA

2. Office of Clinical Pharmacology, Office of Translational Sciences Center for Drug Evaluation and ResearchUS Food and Drug Administration Silver Spring Maryland USA

3. Office of Bioequivalence, Office of Generic Drugs Center for Drug Evaluation and ResearchUS Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2174

Reference39 articles.

1. FDA Draft Guidance for Industry: Bioavailability Studies Submitted in NDAs or INDs — General Considerations (2019). Accessed October 30 2020.

2. FDA Draft Guidance for Industry: Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA (2013). Accessed October 30 2020.

3. Bioavailability of ibuprofen following oral administration of standard ibuprofen, sodium ibuprofen or ibuprofen acid incorporating poloxamer in healthy volunteers

4. Proposing the Use of Partial AUC as an Adjunctive Measure in Establishing Bioequivalence Between Deltoid and Gluteal Administration of Long-Acting Injectable Antipsychotics

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