Very rapid dissolution is not needed to guarantee bioequivalence for biopharmaceutics classification system (BCS) I drugs-Reference-Cited by-同舟云学术

Very rapid dissolution is not needed to guarantee bioequivalence for biopharmaceutics classification system (BCS) I drugs

Published:2010-02 Issue:2 Volume:99 Page:621-625
ISSN:0022-3549
Container-title:Journal of Pharmaceutical Sciences
language:en
Short-container-title:Journal of Pharmaceutical Sciences

Author:

Kortejärvi H.,Shawahna R.,Koski A.,Malkki J.,Ojala K.,Yliperttula M.

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference11 articles.

1. European Medicines Agency (EMEA)2008.Committee for Medicinal Products for human use (CHMP). Draft Guideline on the Investigation of Bioequivalence.

2. European Medicines Agency (EMEA)2002.Committee for Proprietary Medicinal Products (CPMP). Note for guidance on the Investigation of Bioavailability and Bioequivalence.

3. World Health Organization (WHO)2006.Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability. Annex 7. WHO technical report series No. 937.

4. Classification of orally administered drugs on the World Health Organization model list of essential medicines according to the biopharmaceutics classification system;Lindenberg;Eur J Pharm Biopharm,2004

Cited by 16 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. Solubility of lamotrigine in age-specific biorelevant media that simulated the fasted- and fed-conditions of the gastric and intestinal environments in pediatrics and adults: implications for traditional, re-formulated, modified, and new oral formulations;BMC Biotechnology;2023-09-08

2. Quantitative Assessment of the in vivo Dissolution Rate to Establish a Modified IVIVC for Isosorbide Mononitrate Tablets;Journal of Pharmaceutical Sciences;2021-10

3. Evaluating Solubility of Celecoxib in Age-Appropriate Fasted- and Fed-State Gastric and Intestinal Biorelevant Media Representative of Adult and Pediatric Patients: Implications on Future Pediatric Biopharmaceutical Classification System;AAPS PharmSciTech;2021-03-01

4. In silico prediction of bioequivalence of Isosorbide Mononitrate tablets with different dissolution profiles using PBPK modeling and simulation;European Journal of Pharmaceutical Sciences;2021-02

5. Logic of Selecting Suitable Dissolution Parameters in New Drug Formulations Based on A BCS Approach;IRAN J PHARM RES;2020