How Many Batches Are Needed for Process Validation under the New FDA Guidance?

Harry Yang

doi:10.5731/pdajpst.2013.00902

Research ArticleResearch

How Many Batches Are Needed for Process Validation under the New FDA Guidance?

Harry Yang

PDA Journal of Pharmaceutical Science and Technology January 2013, 67 (1) 53-62; DOI: https://doi.org/10.5731/pdajpst.2013.00902

Harry Yang

MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878

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Article Information

vol. 67 no. 1 53-62

DOI

https://doi.org/10.5731/pdajpst.2013.00902

PubMed

23385564

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online February 5, 2013.

Author Information

Harry Yang

MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878

YangH{at}MedImmune.com

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PDA Journal of Pharmaceutical Science and Technology

Vol. 67, Issue 1

January/February 2013

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