Handbook Of Stability Testing In Pharmaceutical Development PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Handbook Of Stability Testing In Pharmaceutical Development PDF full book. Access full book title Handbook Of Stability Testing In Pharmaceutical Development.
Author | : Kim Huynh-Ba |
Publisher | : Springer Science & Business Media |
Total Pages | : 389 |
Release | : 2008-11-16 |
Genre | : Medical |
ISBN | : 0387856277 |
Download Handbook of Stability Testing in Pharmaceutical Development Book 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.
Author | : Kim Huynh-Ba |
Publisher | : Springer Science & Business Media |
Total Pages | : 261 |
Release | : 2009-12-04 |
Genre | : Medical |
ISBN | : 1441908897 |
Download Pharmaceutical Stability Testing to Support Global Markets Book 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.
Author | : Satinder Ahuja |
Publisher | : Academic Press |
Total Pages | : 604 |
Release | : 2010-11-11 |
Genre | : Medical |
ISBN | : 0123759811 |
Download Handbook of Modern Pharmaceutical Analysis Book 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
Author | : Andrew Teasdale |
Publisher | : John Wiley & Sons |
Total Pages | : 740 |
Release | : 2017-10-09 |
Genre | : Medical |
ISBN | : 1118971116 |
Download ICH Quality Guidelines Book 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)
Author | : Shayne Cox Gad |
Publisher | : John Wiley & Sons |
Total Pages | : 857 |
Release | : 2008-04-04 |
Genre | : Science |
ISBN | : 0470259825 |
Download Pharmaceutical Manufacturing Handbook Book 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.
Author | : Satinder Ahuja |
Publisher | : Elsevier |
Total Pages | : 679 |
Release | : 2005-02-09 |
Genre | : Medical |
ISBN | : 0080455182 |
Download Handbook of Pharmaceutical Analysis by HPLC Book in PDF, ePub and Kindle
High pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening). A complete reference guide to HPLC Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling
Author | : Safaraz K. Niazi |
Publisher | : CRC Press |
Total Pages | : 458 |
Release | : 2016-04-19 |
Genre | : Medical |
ISBN | : 1420081314 |
Download Handbook of Pharmaceutical Manufacturing Formulations Book in PDF, ePub and Kindle
No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster
Author | : Carmen Medina |
Publisher | : CRC Press |
Total Pages | : 604 |
Release | : 2003-12-09 |
Genre | : Medical |
ISBN | : 0824740785 |
Download Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics Book in PDF, ePub and Kindle
This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.
Author | : Geoffrey Carr |
Publisher | : Wiley-Blackwell |
Total Pages | : 400 |
Release | : 2012-12-01 |
Genre | : |
ISBN | : 9780470289549 |
Download Pharmaceutical Stability Testing Book in PDF, ePub and Kindle
Stability testing is a critical piece of a drug development program that assesses a potential drug′s shelf life and required storage conditions. Pharmaceutical Stability Testing: A Practical Guide provides a comprehensive guide to the approaches and regulations covering stability testing. The book helps pharmaceutical personnel organize and conduct drug stability tests by describing the many different aspects of drug stability programs, the different types of study that are required, and the approaches pharmaceutical companies apply to ensure that their critical stability programs are secure.
Author | : Shayne Cox Gad |
Publisher | : John Wiley & Sons |
Total Pages | : 1352 |
Release | : 2008-03-21 |
Genre | : Medical |
ISBN | : 0470249021 |
Download Preclinical Development Handbook Book in PDF, ePub and Kindle
A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques. Each chapter is written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor has carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * Modeling and informatics in drug design * Bioanalytical chemistry * Absorption of drugs after oral administration * Transporter interactions in the ADME pathway of drugs * Metabolism kinetics * Mechanisms and consequences of drug-drug interactions Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This publication should be readily accessible to all pharmaceutical scientists involved in preclinical testing, enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.