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)

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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.

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.

New Drug Development

Author : J. Rick Turner
Publisher : Springer Science & Business Media
ISBN 13 : 1441964185
Total Pages : 256 pages
Book Rating : 4.4/5 (419 download)

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Book Synopsis New Drug Development by : J. Rick Turner

Download or read book New Drug Development written by J. Rick Turner and published by Springer Science & Business Media. This book was released on 2010-07-16 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug’s safety and efficacy profiles, and manufacturing considerations. The more inclusive term lifecycle drug development can be used to encompass the postmarketing surveillance that is conducted all the time that a drug is on the market and being prescribed to patients with the relevant clinical condition. Information gathered during this time can be used to modify the drug (for example, dose prescribed, formulation, and mode of administration) in terms of its safety and its effectiveness. The central focus of the first edition of this book is captured by its subtitle, 'Design, Methodology, and Analysis'. Optimum quality study design and experimental research methodology must be employed if the data collected—numerical representations of biological information—are to be of optimum quality. Optimum quality data facilitate optimum quality statistical analysis and interpretation of the results obtained, which in turn permit optimum quality decisions to be made: Rational decision making is predicated on appropriate research questions and optimum quality numerical information. The book took a non-computational approach to statistics, presenting instead a conceptual framework and providing readers with a sound working knowledge of the importance of design, methodology, and analysis. Not everyone needs to be an expert in statistical analysis, but it is very helpful for work (or aspire to work) in the pharmaceutical and biologics industries to be aware of the fundamental importance of a sound scientific and clinical approach to the planning, conduct, and analysis of clinical trials.

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

Author : Louis Rey
Publisher : CRC Press
ISBN 13 : 0203021320
Total Pages : 634 pages
Book Rating : 4.2/5 (3 download)

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Book Synopsis Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Revised and Expanded by : Louis Rey

Download or read book Freeze-Drying/Lyophilization Of Pharmaceutical & Biological Products, Revised and Expanded written by Louis Rey and published by CRC Press. This book was released on 2004-01-21 with total page 634 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Biomarkers in Clinical Drug Development

Author : John Bloom
Publisher : CRC Press
ISBN 13 : 0824755197
Total Pages : 312 pages
Book Rating : 4.8/5 (247 download)

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Book Synopsis Biomarkers in Clinical Drug Development by : John Bloom

Download or read book Biomarkers in Clinical Drug Development written by John Bloom and published by CRC Press. This book was released on 2003-05-20 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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

Modern Pharmaceutics Volume 1

Author : Alexander T. Florence
Publisher : CRC Press
ISBN 13 : 1420065653
Total Pages : 656 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 656 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 route of administration and distribution on drug action • in vivo imaging of dose forms: gamma scintigraphy, PET imaging NMR, MRI, etc. • powder technology • excipient design and characterization • preformulation • optimization techniques in pharmaceutical formulation and processing • disperse and surfactant systems • the solid state, tablet dosage forms, coating processes, and hard and soft shell capsules • parenteral products

Modern Pharmaceutics, Two Volume Set

Author : Alexander T. Florence
Publisher : CRC Press
ISBN 13 : 1420065718
Total Pages : 1216 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 1216 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.

Essentials of Clinical Research

Author : Stephen P. Glasser
Publisher : Springer
ISBN 13 : 3319054708
Total Pages : 461 pages
Book Rating : 4.3/5 (19 download)

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Book Synopsis Essentials of Clinical Research by : Stephen P. Glasser

Download or read book Essentials of Clinical Research written by Stephen P. Glasser and published by Springer. This book was released on 2014-06-02 with total page 461 pages. Available in PDF, EPUB and Kindle. Book excerpt: In its extensively revised and updated Second Edition, this book provides a solid foundation for readers interested in clinical research. Discussion encompasses genetic, pharmacoepidemiologic and implementation research. All chapters have been updated with new information and many new tables have been added to elucidate key points. The book now offers discussion on how to handle missing data when analyzing results, and coverage of Adaptive Designs and Effectiveness Designs and new sections on Comparative Effectiveness Research and Pragmatic Trials. Chapter 6 includes new material on Phase 0 Trials, expanded coverage of Futility Trials, a discussion of Medical Device approval, Off Label Drug use and the role of the FDA in regulating advertising. Additional new information includes the role of pill color and shape in association with the placebo effect and an examination of issues surrounding minority recruitment. The final chapter offers a new section on manuscript preparation along with a discussion of various guidelines being adopted by journals: CONSORT, STROBE, PRISMA, MOOSE and others; and coverage of Conflicts of Interest, Authorship, Coercive Citation, and Disclosures in Industry-Related Associations. Building on the strengths of its predecessor in its comprehensive approach and authoritative advice, the new edition offers more of what has made this book a popular, trusted resource for students and working researchers alike.

Generic Drug Product Development

Author : Isadore Kanfer
Publisher : CRC Press
ISBN 13 : 1420020013
Total Pages : 288 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 288 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 component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be considered for the design and conduct of bioequivalence studies. By exploring scientific, legal, and international regulatory challenges, Generic Drug Development, discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the physical and chemical properties of the active drug and the nature of the drug product.

Advanced Drug Formulation Design to Optimize Therapeutic Outcomes

Author : Robert O. Williams
Publisher : CRC Press
ISBN 13 : 1420043889
Total Pages : 536 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 536 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

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.