[FREE] International Conference on Harmonisation (ICH) Quality Guidelines: Pharmaceutical, Biologics, and Medical Device Guidance Documents Concise Reference
| #1012470 in Books | PharmaLogika | 2010-05-22 | Original language:English | PDF # 1 | 9.00 x1.47 x6.00l,1.89 | File Name: 0982147651 | 650 pages |
||2 of 2 people found the following review helpful.| Unified Source of Information|By JinRNc|Using this book is so much easier than printing it out on your own from the ICH website. It is portable, easy-to-use, and has an excellent index.|About the Author|Mindy Allport-Settle has served as a key executive, board member, and consultant for some of the best companies in the pharmaceutical, medical device, and biotechnology industry. She has provided guidance in regulatory compliance, corporate str
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: Pharmaceuti...
[PDF.wc66] International Conference on Harmonisation (ICH) Quality Guidelines: Pharmaceutical, Biologics, and Medical Device Guidance Documents Concise Reference Rating: 4.68 (498 Votes)
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