Pharmacokinetic Bioequivalence between Generic and Originator Orally Inhaled Drug Products: Validity of Administration of Doses above the Approved Single Maximum Dose-Reference-Cited by-同舟云学术

Pharmacokinetic Bioequivalence between Generic and Originator Orally Inhaled Drug Products: Validity of Administration of Doses above the Approved Single Maximum Dose

Published:2024-08-12 Issue:9 Volume:21 Page:4191-4198
ISSN:1543-8384
Container-title:Molecular Pharmaceutics
language:en
Short-container-title:Mol. Pharmaceutics

Author:

Singh Gur Jai Pal¹^ORCID,Hickey Anthony J²

Affiliation:

1. BBSG Pharm Associates, LLC, 7641 Summer Day Drive, Corona, California 92883, United States

2. Division of Pharmacoengineering and Molecular Pharmaceutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, 125 Mason Farm Road, Chapel Hill, North Carolina 27599, United States

Publisher

American Chemical Society (ACS)

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.molpharmaceut.4c00479

Reference62 articles.

1. Title 21 Code of Federal Regulations, Part 320.24 Types of evidence to measure bioavailability or establish bioequivalence. https://www.ecfr.gov/current/title-21/section-320.24 (accessed Jan 14, 2024).

2. Scientific and regulatory activities initiated by the U.S. Food and drug administration to foster approvals of generic dry powder inhalers: Bioequivalence perspective

3. U.S. Department of Health and Human Services, FDA. Bioanalytical Method Validation Guidance for Industry, 2018. https://www.fda.gov/media/70858/download (Accessed Feb 07, 2024).

4. U.S. Department of Health and Human Services, FDA. Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application [DRAFT GUIDANCE]. Docket Number: FDA-2013-D-1464, August 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioequivalence-studies-pharmacokinetic-endpoints-drugs-submitted-under-abbreviated-new-drug (accessed Feb 02, 2024).

5. Plasma concentrations of fluticasone propionate and budesonide following inhalation from dry powder inhalers by healthy and asthmatic subjects