Analysis of the Regulatory Divergence of Comparative Dissolution Requirements for Post-Approval Manufacturing Changes of Modified Release Solid Oral Dosage Forms-Reference-Cited by-同舟云学术

Analysis of the Regulatory Divergence of Comparative Dissolution Requirements for Post-Approval Manufacturing Changes of Modified Release Solid Oral Dosage Forms

Published:2019-11-04 Issue:1 Volume:22 Page:
ISSN:1550-7416
Container-title:The AAPS Journal
language:en
Short-container-title:AAPS J

Author:

Langer Connie,Diaz Dorys Argelia,Van Alstine Leslie,Bandi Nagesh,Fitzgerald Sarah,Colgan Stephen

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Link

http://link.springer.com/content/pdf/10.1208/s12248-019-0383-1.pdf

Reference28 articles.

1. Department of Health, Therapeutic Goods Administration, Australia. Guidance 15: biopharmaceutic studies, no. Version 1.1, April 2015.

2. National Health Surveillance Agency, Brazil. About the studies of pharmaceutical equivalence and comparative dissolution profile. Collegiate Directory, Vols Resolution-RDC No 31, August 2010.

3. Health Canada. Drugs and Health Products.Post-notice of compliance (NOC) changes: quality document. Vols. File Number 13–107786-650, 2013.

4. China FDA. Center for Drug Evaluation. Technical guidelines for supplementary application of chemical drugs (the second draft). 2015.

5. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on quality of oral modified release products, vol. EMA/CHMP/QWP/428693/2013, 2014.

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