ICH Q8(R2) Pharmaceutical Development

Jtechnology N.

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ICH Q8(R2) Pharmaceutical Development

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Themes

ICH Harmonised Tripartite Guideline, ICH Q8(R2), pharmaceutical development, QbD Quality by Design, risk management, drug substance, manufacturing process, QTPP Quality Target Product Profile, design space, CPP Critical Process Parameters, control strategy, lifecycle management, product quality, PAT Process Analytical Technology, pharmaceutical quality, science-based development, risk-based approach, drug product development

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Abstract

Abstract

The objective of ICH Q8(R2) is to provide guidance for Pharmaceutical Development section (CTD 3.2.P.2), promote scientific and risk-based development, improve product and process understanding and support regulatory flexibility.

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