Japan's first practical guidebook on dissolution testing in Japanese.
The first practical book in Japanese on dissolution testing has finally been published in this country. This book was translated and published in response to strong requests from practitioners in laboratories, managers, and researchers in the pharmaceutical industry. Until now, there has been no specialized book in Japanese that systematically explains the practical aspects of dissolution testing, forcing many in the field to rely on experience and individual literature. The book "Dissolution Testing Handbook, 4th Edition" is based on the content of the already globally standardized 3rd edition in English and comprehensively consolidates all the information one should know about modern dissolution testing, providing detailed explanations on the following wide-ranging topics: - Regulations and Latest Information: Latest updates on the requirements of USP, FDA, and international pharmacopoeias. - Practice and Technology: Steps in method development, problem-solving, and testing methods for special dosage forms. - Quality Control: Control variables, equipment qualification, and responses to automation. - Troubleshooting: Handling abnormal data and investigating the causes of errors and malfunctions. - Latest Additions: Three new chapters on "Pharmacopoeia and Regulatory Guidance," "Method Validation," and "Good Manufacturing Practices (GMP)."
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basic information
**Rich Resources** ● For a deep understanding: Includes detailed references on hundreds of topics ● Pursuit of convenience: Comprehensive appendices covering related information sources and websites Designed to be the most reliable reference book for everyone involved in dissolution testing. In other words, it is an essential book for dissolution laboratories. **Contents of this Book** 1. Overview of dissolution testing 2. Theoretical considerations 3. Official dissolution tests for solid dosage forms 4. Dissolution testing for special formulations 5. Chapters and regulatory guidance on dissolution testing from pharmacopoeias 6. Variability control of dissolution testing equipment 7. Implementation of dissolution testing and equipment validation 8. Development of dissolution testing methods: USP and regulatory considerations 9. Method validation 10. Automation of dissolution testing 11. GMP for dissolution testing laboratories: Root causes of deviations and significant variability
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<Purchase Information> Please contact us through the inquiry section of our website. The price is ¥11,000, including tax and free shipping. If you purchase directly at the exhibition venue, the price is ¥10,000. You can also purchase from Amazon.
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Applications/Examples of results
This book covers and consolidates all the information that one should know about modern dissolution testing, making it an essential resource for management personnel, supervisors, quality control staff at pharmaceutical companies, laboratory chemists in dissolution testing, as well as pharmaceutical researchers and students at universities and research institutions.
Detailed information
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Industry experts Bryan Crist, Vivian Gray, and Royal Hanson have completely revised the "Dissolution Testing Handbook" for modern pharmaceutical industry managers, laboratory supervisors, and bench chemists conducting dissolution testing. It covers all the information you need to know about contemporary dissolution testing, specifically including the following: • The latest information on USP, FDA, and international pharmacopoeia requirements, test method development and challenges, testing of special dosage forms, management of variables and equipment qualification, automation, handling of anomalous data, and causes of errors and defects. • Three new chapters on pharmacopoeial and regulatory guidance in dissolution testing, test method validation, and Good Manufacturing Practices (GMP). • Detailed references on hundreds of topics to deepen understanding. • A convenient and comprehensive appendix covering resources and websites related to dissolution testing. • Designed to be a reliable reference for practitioners in the field, the "Dissolution Testing Handbook, 4th Edition" is an essential book for all dissolution laboratories around the world.
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Company information
Aivic Research was established with the aim of contributing to the improvement of healthcare by helping to enhance the data accuracy of dissolution testing through the provision of excellent dissolution testers and dissolution tester inspection services, as well as introducing the latest dissolution testing information by utilizing various pipes from overseas, thereby supporting the development of the pharmaceutical industry in Japan.
