A comprehensive book that covers various aspects related to regulations and industry trends concerning product quality in the pharmaceutical industry surrounding scale-up, as well as technology transfer in contract manufacturing!
**Features of this Book** - Comprehensive information on regulations and industry trends related to product quality in the pharmaceutical industry surrounding scale-up, as well as technology transfer in contract manufacturing, all in one volume! - Detailed explanations regarding GMP, ICH, PIC/S, equivalence evaluation, raw data, and more! - In-depth discussion on quality issues, impurity management, genotoxic impurities, continuous production, etc.! **Table of Contents** Chapter 1: Basics of Scale-Up Chapter 2: Issues in Scale-Up Chapter 3: Revised Pharmaceutical Affairs Law and GMP Chapter 4: Efficiency and GMP Measures Appendix at the End of the Chapter: The Cutting Edge of UHPLC Chapter 5: Crystal Polymorphism Chapter 6: Troubleshooting in Scale-Up Chapter 7: GMP for Investigational Drugs and Status of New Drug Development Chapter 8: Considerations When Changing Raw Materials and Points for Equivalence Evaluation Chapter 9: Handling of Raw Data and Laboratory Notebooks Chapter 10: What is Data Integrity? Chapter 11: Change Management and Deviation Management Chapter 12: Education and Training Chapter 13: Trends in Pharmaceutical Companies and Generic Drugs/Biosimilars Chapter 14: Flow of Active Pharmaceutical Ingredient Import Business Chapter 15: Trends in Pharmaceutical Companies and Contract Manufacturing Companies Chapter 16: Trends in GDP and Response Measures Afterword *For a detailed table of contents, please refer to the related link URL.*
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■ Release Date: February 20, 2025 ■ Author: Mitsuki Hashimoto ■ Price: Paperback (Black and White) 120,000 yen (tax included 132,000 yen) Book + CD (PDF version Color) 140,000 yen (tax included 154,000 yen) ★ Newsletter members: 10% off the regular price! ■ Format: A4 size, paperback, 639 pages ■ Published by: CMC Research Co., Ltd. ISBN 978-4-910581-62-0
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Booklet version (black and white) 120,000 yen (tax included 132,000 yen) Booklet + CD (PDF version color) 140,000 yen (tax included 154,000 yen)
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Our company monitors market trends for various chemicals, functional materials, and products, and conducts various market research, publishes market information, and supports research and development. Additionally, we also watch market trends in energy, batteries, various chemicals, functional materials, pharmaceuticals, and healthcare. We support research and development through commissioned research, publication of market information, and hosting technical seminars.