Pharmaceutical Photostability And Stabilization Technology

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Pharmaceutical Photostability and Stabilization Technology

Author : Joseph T. Piechocki,Karl Thoma
Publisher : CRC Press
Page : 445 pages
File Size : 44,5 Mb
Release : 2006-09-18
Category : Medical
ISBN : 9781420014136

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Pharmaceutical Photostability and Stabilization Technology by Joseph T. Piechocki,Karl Thoma Pdf

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

Photostability Of Drugs And Drug Formulations

Author : Hanne Hjorth Tonnesen
Publisher : CRC Press
Page : 416 pages
File Size : 43,9 Mb
Release : 1996-09-03
Category : Medical
ISBN : 9780748404490

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Photostability Of Drugs And Drug Formulations by Hanne Hjorth Tonnesen Pdf

This text discusses various aspects of the combination of drugs and light. Degradation processes, stabilization of photolabile drug substances within formulations, benefits from the combination of drugs and light, and testing of drug photoreactivity, are some of the topics discussed.

Pharmaceutical Stress Testing

Author : Steven W. Baertschi,Karen M. Alsante,Robert A. Reed
Publisher : CRC Press
Page : 626 pages
File Size : 53,9 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781439801802

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Pharmaceutical Stress Testing by Steven W. Baertschi,Karen M. Alsante,Robert A. Reed Pdf

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

ICH Quality Guidelines

Author : Andrew Teasdale,David Elder,Raymond W. Nims
Publisher : John Wiley & Sons
Page : 736 pages
File Size : 48,7 Mb
Release : 2017-09-29
Category : Medical
ISBN : 9781118971130

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ICH Quality Guidelines by Andrew Teasdale,David Elder,Raymond W. Nims Pdf

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)

Handbook of Pharmaceutical Granulation Technology

Author : Dilip M. Parikh
Publisher : CRC Press
Page : 678 pages
File Size : 41,7 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781616310035

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Handbook of Pharmaceutical Granulation Technology by Dilip M. Parikh Pdf

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

Photostability of Drugs and Drug Formulations, Second Edition

Author : Hanne Hjorth Tonnesen
Publisher : CRC Press
Page : 450 pages
File Size : 47,7 Mb
Release : 2004-06-29
Category : Medical
ISBN : 9781420023596

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Photostability of Drugs and Drug Formulations, Second Edition by Hanne Hjorth Tonnesen Pdf

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

Essentials of Industrial Pharmacy

Author : Saeed Ahmad Khan
Publisher : Springer Nature
Page : 302 pages
File Size : 45,8 Mb
Release : 2022-05-05
Category : Medical
ISBN : 9783030849771

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Essentials of Industrial Pharmacy by Saeed Ahmad Khan Pdf

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.

Handbook of Modern Pharmaceutical Analysis

Author : Satinder Ahuja,Stephen Scypinski
Publisher : Academic Press
Page : 604 pages
File Size : 54,8 Mb
Release : 2010-11-11
Category : Medical
ISBN : 9780123759818

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Handbook of Modern Pharmaceutical Analysis by Satinder Ahuja,Stephen Scypinski Pdf

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 Statistics

Author : Sanford Bolton,Charles Bon
Publisher : CRC Press
Page : 666 pages
File Size : 44,7 Mb
Release : 2009-12-23
Category : Mathematics
ISBN : 9781420074239

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Pharmaceutical Statistics by Sanford Bolton,Charles Bon Pdf

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.

International Pharmaceutical Product Registration

Author : Anthony C. Cartwright,Brian R. Matthews
Publisher : CRC Press
Page : 804 pages
File Size : 48,5 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420081831

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International Pharmaceutical Product Registration by Anthony C. Cartwright,Brian R. Matthews Pdf

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

Pharmaceutical Project Management

Author : Anthony Kennedy
Publisher : CRC Press
Page : 274 pages
File Size : 53,5 Mb
Release : 2008-03-17
Category : Medical
ISBN : 9781040062920

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Pharmaceutical Project Management by Anthony Kennedy Pdf

Encompassing the full spectrum of project management's role and responsibility encountered in the pharmaceutical industry, Pharmaceutical Project Management outlines the key objectives, risks, and challenges of each stage of the pharmaceutical lifecycle, from discovery and preclinical phases through clinical development, manufacturing, registration

Polymorphism in Pharmaceutical Solids

Author : Harry G. Brittain
Publisher : CRC Press
Page : 656 pages
File Size : 44,5 Mb
Release : 2018-11-12
Category : Medical
ISBN : 9781420073225

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Polymorphism in Pharmaceutical Solids by Harry G. Brittain Pdf

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

Pharmaceutical Process Engineering

Author : Anthony J. Hickey,David Ganderton
Publisher : CRC Press
Page : 230 pages
File Size : 50,8 Mb
Release : 2016-03-09
Category : Medical
ISBN : 9781420084764

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Pharmaceutical Process Engineering by Anthony J. Hickey,David Ganderton Pdf

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

Pharmaceutical Preformulation and Formulation

Author : Mark Gibson
Publisher : CRC Press
Page : 562 pages
File Size : 45,6 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420073188

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Pharmaceutical Preformulation and Formulation by Mark Gibson Pdf

Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, as well as the shift from developing small molecules to the growth of biopharmaceuticals. The book meets the ne

Good Manufacturing Practices for Pharmaceuticals

Author : Joseph D. Nally
Publisher : CRC Press
Page : 418 pages
File Size : 43,8 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420020939

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Good Manufacturing Practices for Pharmaceuticals by Joseph D. Nally Pdf

With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.