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International Conference on Harmonisation (Ich) Quality Guidelines: Pharmaceutical, Biologics, and Medical Device Guidance Documents Concise Reference

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International Conference on Harmonisation (ICH) Quality Guidelines: Pharmaceutical, Biologics, and Medical Device Guidance Documents Concise Reference - Allport-Settle, Mindy J
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ICH Quality Guidelines: * Overview and Orientation * Introduction * Part I: Stability [Q1A(R2), Q1B, Q1C, Q1D, Q1E] * Part II: Analytical Validation [Q2(R1)] * Part III: Impurities [Q3A(R2), Q3B(R2), Q3C(R4)] * Part IV: Pharmacopoeias (List Overview) * Part V: Quality of Biotechnological Products [Q5A(R1), Q5B, Q5C, Q5D, Q5E] * Part VI: Specifications [Q6A, Q6B] * Part VII: Good Manufacturing Practice [Q7] * Part VIII: Pharmaceutical Development [Q8(R2)] * Part IX: Quality Risk Management [Q9] * Part X: Pharmaceutical ...

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International Conference on Harmonisation (ICH) Quality Guidelines: Pharmaceutical, Biologics, and Medical Device Guidance Documents Concise Reference 2010, Pharmalogika

ISBN-13: 9780982147658

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