Handbook of Stability Testing in Pharmaceutical Development - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Handbook of Stability Testing in Pharmaceutical Development write by Kim Huynh-Ba. This book was released on 2008-11-16. Handbook of Stability Testing in Pharmaceutical Development available in PDF, EPUB and Kindle. This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.
Pharmaceutical Stability Testing to Support Global Markets
Pharmaceutical Stability Testing to Support Global Markets - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Pharmaceutical Stability Testing to Support Global Markets write by Kim Huynh-Ba. This book was released on 2009-12-04. Pharmaceutical Stability Testing to Support Global Markets available in PDF, EPUB and Kindle. The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A (R2) was issued over a decade ago, issues surrounding this arena continue to surface as the principles described in the guideline are applied to different technical concentrations. As a result, the stability community has continued to discuss concerns and find ways of harmonizing regulatory requirements, streamlining practices, improving processes in order to bring safe and effective medical supplies to the patients around the world. In 2007, the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group organized two workshops – the Stability Workshop and the Degradation Mechanism Workshop. These meetings attracted many industry scientists as well as representatives from several regulatory agencies in the world to discuss important topics related to pharmaceutical stability practices. Recognizing the importance of documenting these discussions and with the permission of AAPS, I have worked with speakers to assemble a collection of 30 articles from presentations given at these two meetings, mainly the Stability Workshop. I trust that this book will be beneficial to all of you in providing guidance and up-to-date information for building quality stability programs. v Freedom of our mind is Mother of all inventions.
Handbook of Modern Pharmaceutical Analysis
Handbook of Modern Pharmaceutical Analysis - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Handbook of Modern Pharmaceutical Analysis write by Satinder Ahuja. This book was released on 2010-11-11. Handbook of Modern Pharmaceutical Analysis available in PDF, EPUB and Kindle. Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS
Pharmaceutical Manufacturing Handbook
Pharmaceutical Manufacturing Handbook - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Pharmaceutical Manufacturing Handbook write by Shayne Cox Gad. This book was released on 2008-04-04. Pharmaceutical Manufacturing Handbook available in PDF, EPUB and Kindle. With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.
ICH Quality Guidelines
ICH Quality Guidelines - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook ICH Quality Guidelines write by Andrew Teasdale. This book was released on 2017-09-29. ICH Quality Guidelines available in PDF, EPUB and Kindle. Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
