Clinical Drug Trials And Tribulations Revised And Expanded Second Edition
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Clinical Drug Trials And Tribulations Revised And Expanded Second Edition
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Author : Allen Cato
language : en
Publisher: CRC Press
Release Date : 2002-03-26
Clinical Drug Trials And Tribulations Revised And Expanded Second Edition written by Allen Cato and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002-03-26 with Medical categories.
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
DOWNLOAD
Author : Allen Cato
language : en
Publisher: CRC Press
Release Date : 2002-03-26
Clinical Drug Trials And Tribulations Revised And Expanded Second Edition written by Allen Cato and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002-03-26 with Medical categories.
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
DOWNLOAD
Author : Allen Cato
language : en
Publisher: CRC Press
Release Date : 2002-03-26
Clinical Drug Trials And Tribulations Revised And Expanded Second Edition written by Allen Cato and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002-03-26 with Medical categories.
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
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Author : David Machin
language : en
Publisher: John Wiley & Sons
Release Date : 2007-01-11
Textbook Of Clinical Trials written by David Machin and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-01-11 with Mathematics categories.
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
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Author : J. Rick Turner
language : en
Publisher: Springer Science & Business Media
Release Date : 2010-07-16
New Drug Development written by J. Rick Turner and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-07-16 with Medical categories.
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.
Biomarkers In Clinical Drug Development
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Author : John Bloom
language : en
Publisher: CRC Press
Release Date : 2003-05-20
Biomarkers In Clinical Drug Development written by John Bloom and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-05-20 with Medical categories.
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
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Author : Deepak Thassu
language : en
Publisher: CRC Press
Release Date : 2007-03-30
Nanoparticulate Drug Delivery Systems written by Deepak Thassu and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-03-30 with Medical categories.
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
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Author : Isadore Kanfer
language : en
Publisher: CRC Press
Release Date : 2007-11-15
Generic Drug Product Development written by Isadore Kanfer and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-11-15 with Medical categories.
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
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Author : Robert O. Williams
language : en
Publisher: CRC Press
Release Date : 2007-09-25
Advanced Drug Formulation Design To Optimize Therapeutic Outcomes written by Robert O. Williams and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-09-25 with Medical categories.
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
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Author : Alexander T. Florence
language : en
Publisher: CRC Press
Release Date : 2009-05-28
Modern Pharmaceutics Volume 1 written by Alexander T. Florence and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-05-28 with Medical categories.
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