Clinical Endpoint Bioequivalence Studies Are Needed: A Perspective From Brand Drugs-Reference-Cited by-同舟云学术

Clinical Endpoint Bioequivalence Studies Are Needed: A Perspective From Brand Drugs

Published:2018-11-19 Issue:2 Volume:105 Page:298-300
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Krishna Rajesh¹,Kesisoglou Filippos¹

Affiliation:

1. Merck & Co., Inc. Kenilworth New Jersey USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1245

Reference9 articles.

1. Food and Drug Administration.Draft guidance for industry–bioavailability and bioequivalence studies submitted in NDAs or INDs–general considerations. (March 2014). Accessed 21 September 2018.

2. Topical safety and vasoconstrictive assay-based bioequivalence of a new reformulated mometasone cream

3. Food and Drug Administration.Topical dermatologic corticosteroids: in vivo bioequivalence. (June1995). Accessed 23 June 2018.

4. Evaluation of Bioequivalence Between the New Procaterol Hydrochloride Hydrate Dry Powder Inhaler and the Approved Dry Powder Inhaler in Patients With Asthma in a Randomized, Double-Blind, Double-Dummy, Crossover Comparison Study: A Phase 3 Study

5. Food and Drug Administration.Draft guidance on albuterol sulfate. (December2016). Accessed 23 June 2018.

Cited by 4 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Pharmacokinetic Bioequivalence and Safety Assessment of Two Venlafaxine Hydrochloride Extended-Release Capsules in Healthy Chinese Subjects Under Fed Conditions: A Randomized, Open-Label, Single-Dose, Crossover Study;Drugs in R&D;2024-06

2. Pharmacokinetics and Pharmacodynamics of Lansoprazole/Sodium Bicarbonate Immediate‐release Capsules in Healthy Chinese Subjects: An Open, Randomized, Controlled, Crossover, Single‐, and Multiple‐dose Trial;Clinical Pharmacology in Drug Development;2023-05-11

3. Pharmacokinetics and Pharmacodynamics of Esomeprazole/Sodium Bicarbonate Immediate-Release Capsules in Healthy Chinese Volunteers: A Cross-Over, Randomized Controlled Trial;Advances in Therapy;2021-02-11

4. Generic Drugs: Expanding Possibilities for Clinical Pharmacology;Clinical Pharmacology & Therapeutics;2019-01-31