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.
International Stability Testing
International Stability Testing - 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 International Stability Testing write by David J. Mazzo. This book was released on 2020-08-26. International Stability Testing available in PDF, EPUB and Kindle. In this book, recognized industry experts and regulatory inspectors from the world's pharmaceutical manufacturing regions provide stability requirements in all the major markets and discuss all aspects of stability testing and biotechnology. Participants in the ICH debates interpret the ICH guidelines. Other discussions focus on European requirements, the ICH initiatives, the US SUPAC initiative, matrixing and bracketing approaches from the cGMP and FDA perspective, and stability requirements in Japan, Australia, and WHO. Stress programs, testing of preservatives, and physical stability topics are addressed as well as various protocols and statistical approaches.
Handbook of Stability Testing in Pharmaceutical Development
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.
Long Acting Animal Health Drug Products
Long Acting Animal Health Drug Products - 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 Long Acting Animal Health Drug Products write by Michael J. Rathbone. This book was released on 2012-10-12. Long Acting Animal Health Drug Products available in PDF, EPUB and Kindle. Long acting veterinary formulations play a significant role in animal health, production and reproduction within the animal health industry. Such technologies offer beneficial advantages to the veterinarian, farmer and pet owner. These advantages have resulted in them growing in popularity in recent years. The pharmaceutical scientist is faced with many challenges when innovating new products in this demanding field of controlled release. This book provides the reader with a comprehensive guide on the theories, applications, and challenges associated with the design and development of long acting veterinary formulations. The authoritative chapters of the book are written by some of the leading experts in the field. The book covers a wide scope of areas including the market influences, preformulation, biopharmaceutics, in vitro drug release testing and specification setting to name but a few. It also provides a detailed overview of the major technological advances made in this area. As a result this book covers everything a formulation scientist in industry or academia, or a student needs to know about this unique drug delivery field to advance health, production and reproduction treatment options and benefits for animals worldwide.
Regulatory Affairs in the Pharmaceutical Industry
Regulatory Affairs in the Pharmaceutical Industry - 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 Regulatory Affairs in the Pharmaceutical Industry write by Javed Ali. This book was released on 2021-11-14. Regulatory Affairs in the Pharmaceutical Industry available in PDF, EPUB and Kindle. Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
