Pharmaceutical Dissolution Testing: This book is written by Jennifer J. Dressman and Johannes Kramer. You can download it freely in Pdf format. Over the past 20 years, the field of dissolution testing has expanded considerably to address not only dosage form quality control issues, but also to play an important role in formulation screening and testing paradigms. evolving bioequivalence. Through our participation in various workshops conducted by the FIP, AAPS, and APV, it became clear to us that there is an international need for a book that covers all aspects of dissolution testing, from the apparatus to the development of the methodology, the analysis, and interpretation of results. Pharmaceutical Dissolution Testing is our response to this perceived need: a book dedicated to the equipment and methods used to test whether drugs are properly released from dosage forms when administered orally. The focus on orally administered dosage forms results from the predominance of the oral route of administration, on the one hand, and our desire to keep the book to a practicable length, on the other hand.
Dissolution testing is used today in the pharmaceutical industry in a wide variety of applications: to help identify which formulations will produce the best results in the clinic, to bring products to market, to verify lot-to-lot reproducibility, and to help identify whether changes made to formulations or their manufacturing process after marketing approval are likely to affect clinical performance. In addition, dissolution tests can sometimes be implemented to help determine whether or not a generic version of the drug can be approved.
Description:
| Book Name | Pharmaceutical Dissolution Testing |
| Author of Book | Jennifer J. Dressman, and Johannes Kramer |
| Edition | 1st |
| Language | English |
| Format | |
| Category | Pharmaceuticals Books |
Overview of Pharmaceutical Dissolution Testing Pdf Free
According to Jennifer J. Dressman, and Johannes Kramer, The book discusses the different types of equipment that can be used to perform the tests, as well as describes specific information for qualifying equipment and automating procedures. Appropriate design of dissolution tests is put in the context of gastrointestinal physiology and the type of dosage form being developed. Although the discussion in this book focuses on oral dosage forms, the same principles obviously apply to other routes of administration. Just as important as the correct design of the test is the adequate analysis and interpretation of the data obtained. These aspects are covered in detail in several chapters and suggestions are made on how to relate dissolution test results to patient performance (in vitro-in vivo correlation). To reflect the growing interest in dietary supplements and natural products, the last chapter is devoted to special considerations for these products.Topics of this Edition
• Historical Development of Dissolution Testing• Compendial Testing Equipment
• Calibration, Qualification, and Sources of Error
• Compendial Requirements of Dissolution Testing
• The Role of Dissolution Testing in the Regulation of Pharmaceuticals
• The FDA Perspective
• Physiological Parameters Relevant to Dissolution Testing
• Composition of Fluids in the GI Tract
• Physiological Parameters Relevant to Dissolution Testing
• Hydrodynamic Considerations
• Physiological Parameters Relevant to Dissolution Testing
• Behavior of Solid Pharmaceuticals in the GI Tract
• Dissolution Data Analysis with a View to IVIVC
• Analysis and Interpretation of Time Profiles In Vitro and In Vivo
• Pharmacokinetic Study Design with a View to Quality Control
• Dissolution Method Development: An Industrial Perspective
• Design and Qualification of Automated Dissolution Systems
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