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Author : Life Sciences
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (594 download)
Download or read book Stability Testing Design and Interpretation for the International Registration written by Life Sciences and published by . This book was released on 2001 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : BIO-MED.
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (593 download)
Download or read book Stability Testing written by BIO-MED. and published by . This book was released on 1999 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Stability testing - design data and data interpretation for international registration written by and published by . This book was released on 1998 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Joseph T. Piechocki
Publisher : CRC Press
ISBN 13 : 1420014137
Total Pages : 445 pages
Book Rating : 4.4/5 (2 download)
Download or read book Pharmaceutical Photostability and Stabilization Technology written by Joseph T. Piechocki and published by CRC Press. This book was released on 2006-09-18 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: Based on a training course developed by Dr. Joseph T. Piechocki and other experts in this field whose contributions appear in this book for two International Meetings on the Photostability of Drugs and Drug Products, this text clarifies the guidelines set by the International Conference on Harmonization (ICH) and provides a comprehensive background
Author : David J. Mazzo
Publisher : CRC Press
ISBN 13 : 1000161668
Total Pages : 354 pages
Book Rating : 4.0/5 (1 download)
Download or read book International Stability Testing written by David J. Mazzo and published by CRC Press. This book was released on 2020-08-26 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : Kim Huynh-Ba
Publisher : Springer Science & Business Media
ISBN 13 : 0387856277
Total Pages : 389 pages
Book Rating : 4.3/5 (878 download)
Download or read book Handbook of Stability Testing in Pharmaceutical Development written by Kim Huynh-Ba and published by Springer Science & Business Media. This book was released on 2008-11-16 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 :
Publisher :
ISBN 13 :
Total Pages : 342 pages
Book Rating : 4.3/5 (243 download)
Download or read book Federal Register written by and published by . This book was released on 2018 with total page 342 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Jörg Knäblein
Publisher : John Wiley & Sons
ISBN 13 : 352731184X
Total Pages : 2074 pages
Book Rating : 4.5/5 (273 download)
Download or read book Modern Biopharmaceuticals, 4 Volume Set written by Jörg Knäblein and published by John Wiley & Sons. This book was released on 2005-10-28 with total page 2074 pages. Available in PDF, EPUB and Kindle. Book excerpt: The biopharmaceutical market has come along way since 1982 when the first biopharmaceutical product, recombinant human insulin, was launched. Over 120 such products are currently being marketed around the world including nine blockbuster drugs. The global market for biopharmaceuticals, which is currently valued at US$41 billion, has been growing at an impressive compound annual growth rate of 21% over the previous five years. With over one third of all pipe-line products in active development are biopharmaceuticals, this segment is set to continue outperforming the total pharmaceutical market and could easily reach US$100 billion by the end of this decade.
Author : Hanne Hjorth Tonnesen
Publisher : CRC Press
ISBN 13 : 1420023594
Total Pages : 450 pages
Book Rating : 4.4/5 (2 download)
Download or read book Photostability of Drugs and Drug Formulations, Second Edition written by Hanne Hjorth Tonnesen and published by CRC Press. This book was released on 2004-06-29 with total page 450 pages. Available in PDF, EPUB and Kindle. Book excerpt: Providing the guidance needed for formulation, handling, and quality control of photolabile drugs, Photostability of Drugs and Drug Formulations, Second Edition explores the significance of new information on drug photoreactivity in a pharmaceutical context. Completely revised and updated, with chapter authors drawn from an international panel of experts, the book supplies the background necessary for planning standardized photochemical stability studies as a part of drug development and formulation work. It contains comprehensive coverage of the physical and chemical aspects of drug photoreactivity, formulation, stability testing, and drug design/discovery in one resource. The contents have been reorganized to focus on the standardization of photostability testing of drug substances and products, in vitro photoreactivity screening of drugs, and various aspects of the formulation of photoreactive substances. The information on in vitro screening of drug photoreactivity is of great relevance for scientists who are developing and validating a set of testing protocols to address photosafety. Discussing kinetic and chemical aspects of drug photodecomposition as well as the practical problems frequently encountered in photochemical stability testing, this book helps you design a test protocol and interpret the results. Features Assists non-experts in this field design a test protocol and interpret the results Covers in vitro and in vivo aspects of interactions between drugs and light Explores the kinetic and chemical aspects of drug photodecomposition Discusses the problems frequently encountered in photochemical stability testing Provides guidance on how to address photosafety assessments and labeling requirements of potentially photoreactive drugs Highlights the practical implications of drug photodecomposition from a pharmaceutical viewpoint Offers specific guidance in photostability testing and screening of drug photoreactivity
Author : Anne Booth
Publisher : Routledge
ISBN 13 : 1351413813
Total Pages : 425 pages
Book Rating : 4.3/5 (514 download)
Download or read book Sterilization of Medical Devices written by Anne Booth and published by Routledge. This book was released on 2018-12-12 with total page 425 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents vital information on international sterilization standards and guidance on practical application of these standards in the manufacturing process. It covers validation, industrial sterilization methods, emerging sterilization techniques, laboratory testing, manufacturing of sterile devices, and device reuse. Excerpted from The Validator, edited by Anne F. Booth, more than fifty experts share their knowledge of current technologies in easy-to-understand articles that establish methods to ensure compliance. Contents include reviews of ISO sterilization standards, industrial sterilization methods and technologies, and support testing methodologies.
Author : Food and Agriculture Organization of the United Nations
Publisher : Food & Agriculture Org.
ISBN 13 : 9251092656
Total Pages : 305 pages
Book Rating : 4.2/5 (51 download)
Download or read book Manual on development and use of FAO and WHO specifications for pesticides written by Food and Agriculture Organization of the United Nations and published by Food & Agriculture Org.. This book was released on 2016-01-01 with total page 305 pages. Available in PDF, EPUB and Kindle. Book excerpt: The FAO/WHO Manual on development and use of FAO and WHO specifications for pesticides contains general principles and methodologies of the work undertaken by JMPS, is the continuous evaluation of new scientific developments and guidance documents. The Manual gives the historical background of the operation of the JMPS and describes the purpose of the work. The Manual is also used by countries as a guidance document in setting pesticide specifications. This 3rd revision of the Manual contains n ew methodologies/principles developed in recent 5 years and incorporates the current working principles applied by the JMPS.
Author : Christopher M. Riley
Publisher : Elsevier
ISBN 13 : 0081028253
Total Pages : 696 pages
Book Rating : 4.0/5 (81 download)
Download or read book Specification of Drug Substances and Products written by Christopher M. Riley and published by Elsevier. This book was released on 2020-07-23 with total page 696 pages. Available in PDF, EPUB and Kindle. Book excerpt: Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories. Presents a critical assessment of the application of ICH guidelines on method validation and specification setting Written by subject-matter experts involved in the development and application of the guidelines Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction
Author : Robert C. Nelson
Publisher : WCB/McGraw-Hill
ISBN 13 : 9780071158381
Total Pages : 441 pages
Book Rating : 4.1/5 (583 download)
Download or read book Flight Stability and Automatic Control written by Robert C. Nelson and published by WCB/McGraw-Hill. This book was released on 1998 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of Flight Stability and Automatic Control presents an organized introduction to the useful and relevant topics necessary for a flight stability and controls course. Not only is this text presented at the appropriate mathematical level, it also features standard terminology and nomenclature, along with expanded coverage of classical control theory, autopilot designs, and modern control theory. Through the use of extensive examples, problems, and historical notes, author Robert Nelson develops a concise and vital text for aircraft flight stability and control or flight dynamics courses.
Author : Thomas R. Yechout
Publisher : AIAA
ISBN 13 : 9781600860782
Total Pages : 666 pages
Book Rating : 4.8/5 (67 download)
Download or read book Introduction to Aircraft Flight Mechanics written by Thomas R. Yechout and published by AIAA. This book was released on 2003 with total page 666 pages. Available in PDF, EPUB and Kindle. Book excerpt: Based on a 15-year successful approach to teaching aircraft flight mechanics at the US Air Force Academy, this text explains the concepts and derivations of equations for aircraft flight mechanics. It covers aircraft performance, static stability, aircraft dynamics stability and feedback control.
Author : Javed Ali
Publisher : Academic Press
ISBN 13 : 0128222239
Total Pages : 287 pages
Book Rating : 4.1/5 (282 download)
Download or read book Regulatory Affairs in the Pharmaceutical Industry written by Javed Ali and published by Academic Press. This book was released on 2021-11-14 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Author : Yogeshwar Bachhav
Publisher : John Wiley & Sons
ISBN 13 : 3527812180
Total Pages : 498 pages
Book Rating : 4.5/5 (278 download)
Download or read book Innovative Dosage Forms written by Yogeshwar Bachhav and published by John Wiley & Sons. This book was released on 2019-08-20 with total page 498 pages. Available in PDF, EPUB and Kindle. Book excerpt: Teaches future and current drug developers the latest innovations in drug formulation design and optimization This highly accessible, practice-oriented book examines current approaches in the development of drug formulations for preclinical and clinical studies, including the use of functional excipients to enhance solubility and stability. It covers oral, intravenous, topical, and parenteral administration routes. The book also discusses safety aspects of drugs and excipients, as well as regulatory issues relevant to formulation. Innovative Dosage Forms: Design and Development at Early Stage starts with a look at the impact of the polymorphic form of drugs on the preformulation and formulation development. It then offers readers reliable strategies for the formulation development of poorly soluble drugs. The book also studies the role of reactive impurities from the excipients on the formulation shelf life; preclinical formulation assessment of new chemical entities; and regulatory aspects for formulation design. Other chapters cover innovative formulations for special indications, including oncology injectables, delayed release and depot formulations; accessing pharmacokinetics of various dosage forms; physical characterization techniques to assess amorphous nature; novel formulations for protein oral dosage; and more. -Provides information that is essential for the drug development effort -Presents the latest advances in the field and describes in detail innovative formulations, such as nanosuspensions, micelles, and cocrystals -Describes current approaches in early pre-formulation to achieve the best in vivo results -Addresses regulatory and safety aspects, which are key considerations for pharmaceutical companies -Includes case studies from recent drug development programs to illustrate the practical challenges of preformulation design Innovative Dosage Forms: Design and Development at Early Stage provides valuable benefits to interdisciplinary drug discovery teams working in industry and academia and will appeal to medicinal chemists, pharmaceutical chemists, and pharmacologists.
Author : Amit Kumar Nayak
Publisher : Elsevier
ISBN 13 : 0323972470
Total Pages : 488 pages
Book Rating : 4.3/5 (239 download)
Download or read book Physico-Chemical Aspects of Dosage Forms and Biopharmaceutics written by Amit Kumar Nayak and published by Elsevier. This book was released on 2024-08-30 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: Physico-Chemical Aspects of Dosage Forms and Biopharmaceutics: Recent and Future Trends in Pharmaceutics, Volume Two explores aspects of pharmaceutics with an original approach that focuses on technology, novelties and future trends. The field of pharmaceutics is highly dynamic and rapidly expanding day-by-day, so it demands a variety of amplified efforts for designing and developing pharmaceutical processes and formulation strategies. Readers will find practical information for conducting research in pharmaceutics that is ideal for researchers in academia and industry as well as advanced graduate students in pharmaceutics. In addition, the book discusses the most recent developments in biopharmaceutics, including important and exciting areas such as solubility of drugs, pharmaceutical granulation, routes of drug administration, drug absorption, bioavailability and bioequivalence. Provides extensive details on the most recent developments in biopharmaceutics Contains contributions from leading experts from academia, research, industry and regulatory agencies Includes high quality illustrations, flow charts and tables for easier understanding of the concepts Discusses practical examples and research case studies
