Drug Stability Third Edition Revised And Expanded

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Drug Stability, Third Edition, Revised, and Expanded

Author : Jens T. Carstensen,Christopher Rhodes
Publisher : CRC Press
Page : 792 pages
File Size : 48,6 Mb
Release : 2000-07-28
Category : Medical
ISBN : 0824703766

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Drug Stability, Third Edition, Revised, and Expanded by Jens T. Carstensen,Christopher Rhodes Pdf

Addressing concerns for patient welfare while protecting producer reputation, and providing a database for formulation of other products, this multiauthored reference blends fundamental theory and practical advice on drug product stability in scientific, technical, and regulatory environments, covering development of indicating assays, computer use, clinical trial materials, strategic planning, and packaging. Describing the documentation required to minimize the changes of regulatory citations, the book lists manufacturers of photostability testing chambers, stability system software, and laboratory information management systems for pharmaceutical applications.

Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, Third Edition

Author : Linda A. Felton,James W. McGinity
Publisher : CRC Press
Page : 510 pages
File Size : 41,5 Mb
Release : 2008-01-09
Category : Medical
ISBN : 9780849387883

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Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, Third Edition by Linda A. Felton,James W. McGinity Pdf

Thoroughly updated and expanded, this new Third Edition provides the latest information on dosage, forms, film defects, and polymer characterization. Written by renowned leaders in the field, Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms is easily the most comprehensive book available on the market today. New to the Third Edition: the interaction of drugs with functional polymers the influence of processing parameters on coating quality the stabilization of polymeric film coats plasticizers and their applications in pharmaceutical coatings adhesion of polymeric films to solid substrates basic properties of latex and pseudolatex colloidal dispersions Key topics included: polymer interactions with drugs and excipients physical aging of polymeric films a complete overview and in-depth analysis of recent advances in the field, which includes information on the latest equipment used to apply polymers to a pharmaceutical system illustrated examples explaining the appropriate steps to be taken in order to solve formulation, processing, and stability problems to achieve an optimized dosage form

Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition

Author : Allen Cato,Lynda Sutton,Allen Cato III
Publisher : CRC Press
Page : 451 pages
File Size : 55,6 Mb
Release : 2002-03-26
Category : Medical
ISBN : 9780824744809

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Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition by Allen Cato,Lynda Sutton,Allen Cato III Pdf

Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... international regulation and deregulation venture capitalist investment the IND process informed consent changes in manufacturing and updated and extended coverage of... pediatric drug trial design the advantages and disadvantages of orphan drug designations the maximization of package inserts for marketing post approval safety surveillance withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.

Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Revised and Expanded

Author : Louis Rey,Joan C. May
Publisher : CRC Press
Page : 634 pages
File Size : 54,9 Mb
Release : 2004-01-21
Category : Medical
ISBN : 9780203021323

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Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Revised and Expanded by Louis Rey,Joan C. May Pdf

Thoroughly acquainting the reader with freeze-drying fundamentals, Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures. It delineates the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation. With 13 new chapters providing state-of-the-art information, the book unveils innovations currently advancing the field, including LYOGUARD® packaging for bulk freeze-drying and the irradiation of pharmaceutical and biological products.

Pharmaceutical Photostability and Stabilization Technology

Author : Joseph T. Piechocki,Karl Thoma
Publisher : CRC Press
Page : 445 pages
File Size : 49,6 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

Good Manufacturing Practices for Pharmaceuticals

Author : Joseph D. Nally
Publisher : CRC Press
Page : 418 pages
File Size : 47,8 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.

Drug-Drug Interactions

Author : A. David Rodrigues
Publisher : CRC Press
Page : 577 pages
File Size : 53,9 Mb
Release : 2019-01-03
Category : Medical
ISBN : 9780429524301

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Drug-Drug Interactions by A. David Rodrigues Pdf

Authored by renowned leaders in the field, this comprehensive volume covers all aspects of drug-drug interactions, including preclinical, clinical, toxicological, and regulatory perspectives.Thoroughly updated, this second edition reflects the significant advances and includes extensive new material on:key interplay between transporters and enzymes

Filtration and Purification in the Biopharmaceutical Industry

Author : Maik J. Jornitz,Maik W. Jornitz,Theodore H. Meltzer
Publisher : CRC Press
Page : 816 pages
File Size : 51,8 Mb
Release : 2007-11-28
Category : Medical
ISBN : 9780849379543

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Filtration and Purification in the Biopharmaceutical Industry by Maik J. Jornitz,Maik W. Jornitz,Theodore H. Meltzer Pdf

Filtration and Purification in the Biopharmaceutical Industry, First Edition greatly expands its focus with extensive new material on the critical role of purification and the significant advances in filtration science and technology. This new edition provides state-of-the-science information on all aspects of filtration and purification, in

Pharmaceutical Inhalation Aerosol Technology, Second Edition

Author : Anthony J. Hickey
Publisher : CRC Press
Page : 628 pages
File Size : 54,7 Mb
Release : 2003-09-03
Category : Medical
ISBN : 9780824756642

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Pharmaceutical Inhalation Aerosol Technology, Second Edition by Anthony J. Hickey Pdf

This thoroughly revised and expanded reference provides authoritative discussions on the physiologic, pharmacologic, metabolic, molecular, cellular and physicochemical factors, influencing the efficacy and utilization of pharmaceutical aerosol. It analyzes the latest science and developments in the generation, administration and characterization of these compounds, showcasing current clinical applications, the efficiency and limitations of major aerosol products and emerging aerosol therapies impacting the field.

Transdermal Drug Delivery Systems

Author : Jonathan Hadgraft
Publisher : CRC Press
Page : 400 pages
File Size : 45,5 Mb
Release : 2002-10-29
Category : Medical
ISBN : 9780203909683

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Transdermal Drug Delivery Systems by Jonathan Hadgraft Pdf

Presents authoritative state-of-the-art discussions of the key issues pertinent to transdermal drug delivery, examining those topics necessary to enable a critical evaluation of a drug candidate's potential to be delivered across the skin; from physical chemistry and assessment of drug permeability to available enhancement technolgies, to regulator

Drug Targeting Technology

Author : Hans Schreier
Publisher : CRC Press
Page : 320 pages
File Size : 50,5 Mb
Release : 2001-08-09
Category : Medical
ISBN : 9780203908563

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Drug Targeting Technology by Hans Schreier Pdf

Demonstrates how substitution of a variety of ligands can render albumin a versatile targeting tool for selective drug accumulation in various cell populations of the liver! This book discusses physical, chemical, and biological approaches to drug targeting technology, focusing on oral, dispersed system, topical, dermal, transdermal, and inh

Handbook of Drug Screening

Author : Ramakrishna Seethala,Prabhavathi Fernandes
Publisher : CRC Press
Page : 619 pages
File Size : 41,7 Mb
Release : 2001-07-24
Category : Medical
ISBN : 9780824741440

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Handbook of Drug Screening by Ramakrishna Seethala,Prabhavathi Fernandes Pdf

A presentation of screening techniques, modern technologies, and high-capacity instrumentation for increased productivity in the development and discovery of new drugs, chemical compounds, and targeted delivery of pharmaceuticals. It contains practical applications and examples of strategies in cell-based and cell-free screens as well as homogeneous, fluorescence, chemiluminescence, and radioactive-based technologies.

Biomarkers in Clinical Drug Development

Author : John Bloom,Richard A. Dean
Publisher : CRC Press
Page : 312 pages
File Size : 44,5 Mb
Release : 2003-05-20
Category : Medical
ISBN : 9780824755195

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Biomarkers in Clinical Drug Development by John Bloom,Richard A. Dean Pdf

Presenting applications in clinical development, pharmacokinetic/ pharmacodynamic modelling and clinical trial simulation, this reference studies the role of biomarkers in successful drug formulation and development.

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Author : Sarfaraz K. Niazi
Publisher : CRC Press
Page : 420 pages
File Size : 43,8 Mb
Release : 2019-11-25
Category : Medical
ISBN : 9781351593601

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Handbook of Pharmaceutical Manufacturing Formulations, Third Edition by Sarfaraz K. Niazi Pdf

The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Two, Uncompressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this second volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author’s own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent. Features:  Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions  Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing  Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements  Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines

Pharmaceutical Gene Delivery Systems

Author : Alain Rolland
Publisher : CRC Press
Page : 442 pages
File Size : 49,7 Mb
Release : 2003-04-11
Category : Medical
ISBN : 9780824748586

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Pharmaceutical Gene Delivery Systems by Alain Rolland Pdf

This volume examines the advantages and limitations of the major gene delivery systems and offers guidelines to select the most appropriate viral or synthetic delivery system for specific therapeutic applications. It discusses advances in the design, optimization, and adaptation of gene delivery systems for the treatment of cancerous, cardiovascular, pulmonary, genetic, and infectious diseases.