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ICH Q - S - E - M Series Handbooks

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CFR Rule Changes by GXPNews
ICH E2A
1-933734-72-8
Clinical Safety Data Management : Definitions and Standards for Expedited Reporting
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ICH E4
1-933734-74-4
Dose-Response Information to Support Drug Registration
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ICH E6
1-933734-75-2
Good Clinical Practice
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ICH E8
1-933734-76-0
General Considerations for Clinical Trials
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ICH M3(M)
1-933734-77-9
Timing of Pre-clinical Studies in Relation to Clinical Trials
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
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ICH Q10
978-1-935131-62-5
Step 3 Pharmaceutical Quality Systems Handbook
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ICH Q1A

Stability Testing of New Drug Substances and Products (2nd Revision)
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
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ICH Q1E

Evaluation of Stability Data
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ICH Q2B
1-933734-93-0
Validation of Analytical Procedures : Methodology
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Price $3.20 $3.10 $2.90 $2.75 $2.45
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ICH Q5E
1-933734-81-7
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
Quantity   1 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $7.90 $7.60 $7.25 $6.50 $5.95

Quantity   
ICH Q8
1-933734-83-3
Pharmaceutical Development
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Price $3.20 $3.10 $2.90 $2.75 $2.45
5 Book Minimum

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ICH Q8 and Q9
1-933734-85-X
Combination Booklet Q8 - Pharmaceutical Development Q9 - Quality Risk Management
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Price $3.20 $3.10 $2.90 $2.75 $2.45

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ICH Q8, Q9 & Q10 Combination
978-1-935131-61-8
Combination Handbook for Pharmaceutical Quality Includes; Q8 - Pharmaceutical Development Q9 - Quality Risk Management Q10 - Pharmaceutical Quality Systems Handbook
Quantity   1 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $6.90 $6.80 $5.90 $5.75 $5.45

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ICH Q9
1-933734-84-1
Quality Risk Management
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $3.20 $3.10 $2.90 $2.75 $2.45
5 Book Minimum

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ICH S2A
1-933734-89-2
Guidance on Specific Aspects of Regulatory Tests for Pharmaceuticals
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ICH S6
1-933734-86-8
Preclinical Safety Evaluation of Biotechnology - Derived Pharmaceuticals
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $3.20 $3.10 $2.90 $2.75 $2.45
5 Book Minimum

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ICH S7A
1-933734-87-6
Safety Pharmacology Studies for Human Pharmaceuticals
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $3.20 $3.10 $2.90 $2.75 $2.45
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