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Author: Joseph T. Piechocki Publisher: CRC Press ISBN: 1420014137 Category : Medical Languages : en Pages : 445
Book Description
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: Joseph T. Piechocki Publisher: CRC Press ISBN: 1420014137 Category : Medical Languages : en Pages : 445
Book Description
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: Steven W. Baertschi Publisher: CRC Press ISBN: 1439801800 Category : Medical Languages : en Pages : 626
Book Description
The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability
Author: Andrew Teasdale Publisher: John Wiley & Sons ISBN: 1118971132 Category : Medical Languages : en Pages : 624
Book Description
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: Dilip M. Parikh Publisher: CRC Press ISBN: 1616310030 Category : Medical Languages : en Pages : 678
Book Description
The Third Edition presents all pharmaceutical industry personnel and those in academia with critical updates on the recent advances in granulation technology and changes in FDA regulatory guidelines. Addressing precisely how these recent innovations and revisions affect unit operation of particle generation and granulation, this text assists the re
Author: Saeed Ahmad Khan Publisher: Springer Nature ISBN: 3030849775 Category : Medical Languages : en Pages : 302
Book Description
Essentials of Industrial Pharmacy is an attempt to comprehensively present, in a single book, various pharmaceutical processes and equipment that are frequently used for production of pharmaceutical dosage forms, along with quality control tests of these dosage forms. Pictorial/graphical illustrations provide easier understanding of complex pharmaceutical concepts, manufacturing processes of pharmaceutical dosage forms. Since it is imperative for pharmacy students to have a clear understanding of the basic concepts used in development of drugs into suitable and stable dosage forms. This book offers a wealth of information regarding basic aspects of pharmaceutical processes and dosage forms, in a single book, for undergraduate pharmacy students or science students (with no pharmacy background) intended to work in the pharmaceutical Industry.
Author: Satinder Ahuja Publisher: Academic Press ISBN: 0123759811 Category : Medical Languages : en Pages : 604
Book Description
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: Sanford Bolton Publisher: CRC Press ISBN: 1420074237 Category : Mathematics Languages : en Pages : 666
Book Description
Through the use of practical examples and solutions, Pharmaceutical Statistics: Practical and Clinical Applications, Fifth Edition provides the most complete and comprehensive guide to the various statistical applications and research issues in the pharmaceutical industry, particularly in clinical trials and bioequivalence studies.
Author: Anthony C. Cartwright Publisher: CRC Press ISBN: 1420081837 Category : Medical Languages : en Pages : 804
Book Description
Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.This cutting-edge resou
Author: Anthony J. Hickey Publisher: CRC Press ISBN: 1420084763 Category : Medical Languages : en Pages : 230
Book Description
With step-by-step methods of drug production and knowledge of major unit operations and key concepts of pharmaceutical engineering, this guide will help to improve communication among the varied professionals working in the pharmaceutical industry. Key features: REVISION OF A BESTSELLER - Updates include recent advances in the field to keep pharmac
Author: Harry G. Brittain Publisher: CRC Press ISBN: 1420073222 Category : Medical Languages : en Pages : 656
Book Description
Using clear and practical examples, Polymorphism of Pharmaceutical Solids, Second Edition presents a comprehensive examination of polymorphic behavior in pharmaceutical development that is ideal for pharmaceutical development scientists and graduate students in pharmaceutical science. This edition focuses on pharmaceutical aspects of polymorphism a
Author: Joseph T. Piechocki
Author: Joseph T. Piechocki
Author: Steven W. Baertschi
Author: Andrew Teasdale
Author: Dilip M. Parikh
Author: Saeed Ahmad Khan
Author: Satinder Ahuja
Author: Sanford Bolton
Author: Anthony C. Cartwright
Author: Anthony J. Hickey
Author: Harry G. Brittain