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ICH Series Handbooks
ICH E2A
ICH E2A
Clinical Safety Data Management : Definitions and Standards for Expedited Reporting
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5 Book Minimum
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ICH E4
ICH E4
Dose-Response Information to Support Drug Registration
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ICH E6
ICH E6
Good Clinical Practice
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ICH E8
ICH E8
General Considerations for Clinical Trials
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ICH M3(M)
ICH M3(M)
Timing of Pre-clinical Studies in Relation to Clinical Trials
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ICH Q10
ICH Q10
Pharmaceutical Quality Systems Handbook
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5 Book Minimum

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ICH Q1A
ICH Q1A
Stability Testing of New Drug Substances and Products (2nd Revision)
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ICH Q1E
ICH Q1E
Evaluation of Stability Data
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5 Book Minimum

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ICH Q2(R1)
ICH Q2B
Validation of Analytical Procedures : Methodology
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5 Book Minimum

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ICH Q5E
ICH Q5E
Comparability of Biotechnological / Biological Products Subject to Changes in their Manufacturing Process
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ICH Q7
1-933734-82-5
Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
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ICH Q7, Q8, Q9 & Q10 Combination
978-1-935131-60-1
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ICH Q8
ICH Q8
Pharmaceutical Development
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5 Book Minimum

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ICH Q9
ICH Q9
Quality Risk Management
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5 Book Minimum

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ICH S2A
ICH S2A
Guidance on Specific Aspects of Regulatory Tests for Pharmaceuticals
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ICH S6
ICH S6
Preclinical Safety Evaluation of Biotechnology - Derived Pharmaceuticals
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Price $3.20 $3.10 $2.90 $2.75 $2.45
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ICH S7A
ICH S7A
Safety Pharmacology Studies for Human Pharmaceuticals
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Price $3.20 $3.10 $2.90 $2.75 $2.45
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