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Drug Development|

Quality Systems

Brian T. Connell

Articles by Brian T. Connell

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Regulatory Considerations for Controlling Intermediates in Type-II Drug Master Files for the Manufacture of Generic Drug Substances

ByDavid J. Skanchy,Kandasamy Subburaj,Srinivasa Murthy,Humcha Hariprakasha,Brian T. Connell,Huyi Zhang,Deborah F. Johnson

March 15th 2016

The authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.

Latest Updated Articles

Regulatory Considerations for Controlling Intermediates in Type-II Drug Master Files for the Manufacture of Generic Drug Substances
Published: March 15th 2016 | Updated:

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