Development strategies for IVIVC in an industrial environment-Reference-Cited by-同舟云学术

Development strategies for IVIVC in an industrial environment

Published:2012-05-29 Issue:7 Volume:33 Page:349-353
ISSN:0142-2782
Container-title:Biopharmaceutics & Drug Disposition
language:en
Short-container-title:Biopharm. Drug Dispos.

Author:

Cook Jack A.¹

Affiliation:

1. Department of Clinical Pharmacology, Pfizer, Inc.; Groton; USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmaceutical Science,Pharmacology,General Medicine

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/bdd.1791/fullpdf

Reference18 articles.

1. FDA Guidance for Industry: Extended Release Oral Dosage Forms; Development, Evaluation, and application of in vitro / in vivo correlations 1997 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070

2. Regulatory perspectives on in vitro (dissolution)/in vivo (bioavailability) correlations;Uppoor;J Control Release,2001

3. The concept of pharmaceutical quality;Woodcock;Am Pharm Rev,2004

4. Process robustness: A PQRI white paper;Glodek;Pharm Eng,2006

5. FDA Guidance for Industry: Q8(R2) Pharmaceutical Development 2009 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073507.pdf

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