PDA TR 57-2012

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Analytical Method Validation and Transfer for Biotechnology Products

This technical report is to provide practical and strategic guidance to efficiently use historical data and knowledge to design suitable risk-based AMV studies, and set appropriate protocol acceptance criteria.a

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Parenteral Drug Association [pda]

Historical

Analytical Method Validation and Transfer for Biotechnology Products

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Historical

PDA TR 57-2012

Analytical Method Validation and Transfer for Biotechnology Products

Are the documents at the ANSI Webstore in electronic Adobe Acrobat PDF format only?

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