ICH Series Handbooks
| GMP International Master Reference Guide |
| GMP Manufacturing Handbook |
| ICH E2A - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting |
| ICH E4 - Dose-Response Information to Support Drug Registration |
| ICH E6(R2) - Good Clinical Practice |
| ICH E8 - General Considerations for Clinical Studies |
| ICH M3(R2) - Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals |
| ICH Q10 - Pharmaceutical Quality System |
| ICH Q1A(R2) - Stability Testing of New Drug Substances and Products |
| ICH Q1E - Evaluation of Stability Data |
| ICH Q2(R1) - Validation of Analytical Procedures: Text and Methodology |
| ICH Q2(R2) and ICH Q14 Analytical Validation |
| ICH Q5E - Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process |
| ICH Q7, ICH Q8(R2), ICH Q9(R1), ICH Q10 and ICH Q12 Combination |
| ICH Q7, Q8(R2), Q9(R1) and Q10 Combination |
| ICH Q7, Q8(R2), Q9(R1) and Q10 with FAQ |
| ICH Q7, Q8(R2), Q9(R1), Q10 and Q11 |
| ICH Q8(R2) - Pharmaceutical Development |
| ICH Q9(R1) - Quality Risk Management |
| ICH S2(R1) - Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use |
| ICH S6 - Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals |
| ICH S7A - Safety Pharmacology Studies for Human Pharmaceuticals |
| Parts 11, 606 and 1271 - Blood, Cell & Tissue with Annex 14 |
| Title 21 CFR Parts 1 - End Nine Volume Set |
| VICH GL9 Animal GCP |
|
- Guaranteed Lowest Price
- Quantity Discounts Available
- Always Current, Up-To-Date
- Company Logos Available
- Special Customizations
- Pocket-sized 3.75" x 6.25"
- Prep for FDA & Client Audits
- Employee Training & Reference
- Promotional "giveaways"
- Tradeshows and meetings
-
|
