Clinical Drug Trials And Tribulations Revised And Expanded Second Edition

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

Author : Allen Cato
Publisher : CRC Press
ISBN 13 : 0824744802
Total Pages : 451 pages
Book Rating : 4.8/5 (247 download)

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Book Synopsis Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition by : Allen Cato

Download or read book Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition written by Allen Cato and published by CRC Press. This book was released on 2002-03-26 with total page 451 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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

Author : Allen Cato
Publisher : CRC Press
ISBN 13 : 9780824703141
Total Pages : 368 pages
Book Rating : 4.7/5 (31 download)

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Book Synopsis Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition by : Allen Cato

Download or read book Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition written by Allen Cato and published by CRC Press. This book was released on 2002-03-26 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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

Author : Allen Cato
Publisher : CRC Press
ISBN 13 : 9781135556730
Total Pages : 368 pages
Book Rating : 4.5/5 (567 download)

DOWNLOAD NOW!

Book Synopsis Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition by : Allen Cato

Download or read book Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition written by Allen Cato and published by CRC Press. This book was released on 2002-03-26 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Textbook of Clinical Trials

Author : David Machin
Publisher : John Wiley & Sons
ISBN 13 : 0470010150
Total Pages : 784 pages
Book Rating : 4.4/5 (7 download)

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Book Synopsis Textbook of Clinical Trials by : David Machin

Download or read book Textbook of Clinical Trials written by David Machin and published by John Wiley & Sons. This book was released on 2007-01-11 with total page 784 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now published in its Second Edition, the Textbook of Clinical Trials offers detailed coverage of trial methodology in diverse areas of medicine in a single comprehensive volume. Praise for the First Edition: "... very useful as an introduction to clinical research, or for those planning specific studies within therapeutic or disease areas." BRITISH JOURNAL OF SURGERY, Vol. 92, No. 2, February 2005 The book’s main concept is to describe the impact of clinical trials on the practice of medicine. It separates the information by therapeutic area because the impact of clinical trials, the problems encountered, and the numbers of trials in existence vary tremendously from specialty to specialty. The sections provide a background to the disease area and general clinical trial methodology before concentrating on particular problems experienced in that area. Specific examples are used throughout to address these issues. The Textbook of Clinical Trials, Second Edition: Highlights the various ways clinical trials have influenced the practice of medicine in many therapeutic areas Describes the challenges posed by those conducting clinical trials over a range of medical specialities and allied fields Additional therapeutic areas are included in this Second Edition to fill gaps in the First Edition as the number and complexity of trials increases in this rapidly developing area Newly covered or updated in the Second Edition: general surgery, plastic surgery, aesthetic surgery, palliative care, primary care, anaesthesia and pain, transfusion, wound healing, maternal and perinatal health, early termination, organ transplants, ophthalmology, epilepsy, infectious disease, neuro-oncology, adrenal, thyroid and urological cancers, as well as a chapter on the Cochrane network An invaluable resource for pharmaceutical companies, the Textbook of Clinical Trials, Second Edition appeals to those working in contract research organizations, medical departments and in the area of public health and health science alike.

Nanoparticulate Drug Delivery Systems

Author : Deepak Thassu
Publisher : CRC Press
ISBN 13 : 1420008447
Total Pages : 373 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Nanoparticulate Drug Delivery Systems by : Deepak Thassu

Download or read book Nanoparticulate Drug Delivery Systems written by Deepak Thassu and published by CRC Press. This book was released on 2007-03-30 with total page 373 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the advent of analytical techniques and capabilities to measure particle sizes in nanometer ranges, there has been tremendous interest in the use of nanoparticles for more efficient methods of drug delivery. Nanoparticulate Drug Delivery Systems addresses the scientific methodologies, formulation, processing, applications, recent trends, and e

Generic Drug Product Development

Author : Isadore Kanfer
Publisher : CRC Press
ISBN 13 : 1420020013
Total Pages : 287 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Generic Drug Product Development by : Isadore Kanfer

Download or read book Generic Drug Product Development written by Isadore Kanfer and published by CRC Press. This book was released on 2007-11-15 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important comp

Advanced Drug Formulation Design to Optimize Therapeutic Outcomes

Author : Robert O. Williams
Publisher : CRC Press
ISBN 13 : 1420043889
Total Pages : 532 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Advanced Drug Formulation Design to Optimize Therapeutic Outcomes by : Robert O. Williams

Download or read book Advanced Drug Formulation Design to Optimize Therapeutic Outcomes written by Robert O. Williams and published by CRC Press. This book was released on 2007-09-25 with total page 532 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title demonstrates how advanced formulation designs and delivery technologies can be used to improve drug efficacy and treatment outcomes in particular therapeutic categories or disease states. It discusses nanoparticle systems for cancer treatments, and also presents cutting edge immono-regulation agents for transplantation and the local targ

Modern Pharmaceutics Volume 1

Author : Alexander T. Florence
Publisher : CRC Press
ISBN 13 : 1420065653
Total Pages : 630 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Modern Pharmaceutics Volume 1 by : Alexander T. Florence

Download or read book Modern Pharmaceutics Volume 1 written by Alexander T. Florence and published by CRC Press. This book was released on 2009-05-28 with total page 630 pages. Available in PDF, EPUB and Kindle. Book excerpt: With over 100 illustrations, Volume 1 addresses the core disciplines of pharmaceutics (absorption, PK, excipients, tablet dosage forms, and packaging), and explores the challenges and paradigms of pharmaceutics.Key topics in Volume 1 include: principles of drug absorption, chemical kinetics, and drug stability pharmacokinetics the effect of rout

Modern Pharmaceutics, Two Volume Set

Author : Alexander T. Florence
Publisher : CRC Press
ISBN 13 : 1420065718
Total Pages : 1220 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Modern Pharmaceutics, Two Volume Set by : Alexander T. Florence

Download or read book Modern Pharmaceutics, Two Volume Set written by Alexander T. Florence and published by CRC Press. This book was released on 2016-04-19 with total page 1220 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new edition brings you up-to-date on the role of pharmaceutics and its future paradigms in the design of medicines. Contributions from over 30 international thought leaders cover the core disciplines of pharmaceutics and the impact of biotechnology, gene therapy, and cell therapy on current findings. Modern Pharmaceutics helps you stay current

Supercritical Fluid Technology for Drug Product Development

Author : Peter York
Publisher : CRC Press
ISBN 13 : 0824751027
Total Pages : 640 pages
Book Rating : 4.8/5 (247 download)

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Book Synopsis Supercritical Fluid Technology for Drug Product Development by : Peter York

Download or read book Supercritical Fluid Technology for Drug Product Development written by Peter York and published by CRC Press. This book was released on 2004-03-23 with total page 640 pages. Available in PDF, EPUB and Kindle. Book excerpt: Interconnecting the fundamentals of supercritical fluid (SCF) technologies, their current and anticipated utility in drug delivery, and process engineering advances from related methodological domains and pharmaceutical applications, this volume unlocks the potential of supercritical fluids to further the development of improved pharmaceutical products-from drug powders for respiratory delivery to drug delivery systems for controlled release.

Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, Third Edition

Author : Linda A. Felton
Publisher : CRC Press
ISBN 13 : 0849387884
Total Pages : 510 pages
Book Rating : 4.8/5 (493 download)

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Book Synopsis Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, Third Edition by : Linda A. Felton

Download or read book Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, Third Edition written by Linda A. Felton and published by CRC Press. This book was released on 2008-01-09 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics

Author : Carmen Medina
Publisher : CRC Press
ISBN 13 : 0824740785
Total Pages : 604 pages
Book Rating : 4.8/5 (247 download)

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Book Synopsis Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics by : Carmen Medina

Download or read book Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics written by Carmen Medina and published by CRC Press. This book was released on 2003-12-09 with total page 604 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Pharmaceutical Product Development

Author : Chilukuri Dakshina Murthy
Publisher : CRC Press
ISBN 13 : 100061154X
Total Pages : 228 pages
Book Rating : 4.0/5 (6 download)

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Book Synopsis Pharmaceutical Product Development by : Chilukuri Dakshina Murthy

Download or read book Pharmaceutical Product Development written by Chilukuri Dakshina Murthy and published by CRC Press. This book was released on 2007-02-12 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: During the last two decades, the pharmaceutical industry has been under pressure to reduce development costs and the time needed to bring drugs to market in order to maximize return on investment and bring treatments to patients sooner. To meet these ends, pharmaceutical scientists working in the differing areas of pharmacy, pharmaceutics, and phar

Pharmaceutical Inhalation Aerosol Technology, Second Edition

Author : Anthony J. Hickey
Publisher : CRC Press
ISBN 13 : 0824756649
Total Pages : 628 pages
Book Rating : 4.8/5 (247 download)

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Book Synopsis Pharmaceutical Inhalation Aerosol Technology, Second Edition by : Anthony J. Hickey

Download or read book Pharmaceutical Inhalation Aerosol Technology, Second Edition written by Anthony J. Hickey and published by CRC Press. This book was released on 2003-09-03 with total page 628 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Dermal Absorption and Toxicity Assessment

Author : Michael S. Roberts
Publisher : CRC Press
ISBN 13 : 0849375924
Total Pages : 704 pages
Book Rating : 4.8/5 (493 download)

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Book Synopsis Dermal Absorption and Toxicity Assessment by : Michael S. Roberts

Download or read book Dermal Absorption and Toxicity Assessment written by Michael S. Roberts and published by CRC Press. This book was released on 2007-12-14 with total page 704 pages. Available in PDF, EPUB and Kindle. Book excerpt: The source Dermal Absorption and Toxicity Assessment supplies a state-of-the-art overview of the dermal absorption process, and is divided into six well organized sections. Written by internationally recognized experts in the field, this Second Edition is a complete revised and updated text, covering the wide range of methods used to assess skin ab

Filtration and Purification in the Biopharmaceutical Industry

Author : Maik J. Jornitz
Publisher : CRC Press
ISBN 13 : 0849379547
Total Pages : 816 pages
Book Rating : 4.8/5 (493 download)

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Book Synopsis Filtration and Purification in the Biopharmaceutical Industry by : Maik J. Jornitz

Download or read book Filtration and Purification in the Biopharmaceutical Industry written by Maik J. Jornitz and published by CRC Press. This book was released on 2007-11-28 with total page 816 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Good Laboratory Practice Regulations

Author : Sandy Weinberg
Publisher : CRC Press
ISBN 13 : 0849375843
Total Pages : 306 pages
Book Rating : 4.8/5 (493 download)

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Book Synopsis Good Laboratory Practice Regulations by : Sandy Weinberg

Download or read book Good Laboratory Practice Regulations written by Sandy Weinberg and published by CRC Press. This book was released on 2007-01-19 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresse