Clinical Research In Pharmacology

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Pharmaceutical Medicine and Translational Clinical Research

Divya Vohora,Gursharan Singh
Pharmaceutical Medicine and Translational Clinical Research Book PDF

Author : Divya Vohora,Gursharan Singh
Publisher : Academic Press
Page : 526 pages
File Size : 43,8 Mb
Release : 2017-11-14
Category : Medical
ISBN : 9780128020982

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Pharmaceutical Medicine and Translational Clinical Research by Divya Vohora,Gursharan Singh Pdf

Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features. As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery

Clinical Pharmacology: Current Topics and Case Studies

Markus Müller
Clinical Pharmacology Current Topics and Case Studies Book PDF

Author : Markus Müller
Publisher : Springer Science & Business Media
Page : 438 pages
File Size : 49,7 Mb
Release : 2011-02-04
Category : Medical
ISBN : 9783709101445

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Clinical Pharmacology: Current Topics and Case Studies by Markus Müller Pdf

Today we witness an eventful time in which the powerful new forces of genomics, information technology and economics are rapidly changing the science and art of medicine. This will require more specialization than ever before. However, there is also an increasing demand for an integrated approach, which is provided by the discipline of Clinical Pharmacology (CP). CP pursues a scientific goal by studying drug action in patients and volunteers, a clinical goal by administering appropriate drug therapy and a regulatory goal by assessing the risk/benefit ratio of drug candidates in drug development and reimbursement. This introduction to current topics of CP covers traditional topics of clinical drug research and trial methodology but also provides insight in current topics like genomics, imaging technology and issues in drug reimbursement. A number of concrete case studies in clinical drug research and development help to give a better understanding of the general principles of CP.

The Role of Purchasers and Payers in the Clinical Research Enterprise

Institute of Medicine,Board on Health Sciences Policy,Clinical Research Roundtable
The Role of Purchasers and Payers in the Clinical Research Enterprise Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Clinical Research Roundtable
Publisher : National Academies Press
Page : 120 pages
File Size : 41,9 Mb
Release : 2002-06-14
Category : Medical
ISBN : 9780309182904

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The Role of Purchasers and Payers in the Clinical Research Enterprise by Institute of Medicine,Board on Health Sciences Policy,Clinical Research Roundtable Pdf

In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective.

The Prevention and Treatment of Missing Data in Clinical Trials

National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials
The Prevention and Treatment of Missing Data in Clinical Trials Book PDF

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials
Publisher : National Academies Press
Page : 163 pages
File Size : 43,8 Mb
Release : 2010-12-21
Category : Medical
ISBN : 9780309186513

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The Prevention and Treatment of Missing Data in Clinical Trials by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials Pdf

Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

The Clinical Research Process in the Pharmaceutical Industry

Gary M. Matoren
The Clinical Research Process in the Pharmaceutical Industry Book PDF

Author : Gary M. Matoren
Publisher : CRC Press
Page : 584 pages
File Size : 40,5 Mb
Release : 2020-08-18
Category : Business & Economics
ISBN : 9781000148718

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The Clinical Research Process in the Pharmaceutical Industry by Gary M. Matoren Pdf

This book examines the sequence of events and methodology in the industrial clinical research process; a reference for multidisciplinary personnel. It is the conceptual framework involving the philosophical, economic, political, historical, regulatory, planning, and marketing aspects of the process.

Principles of Clinical Pharmacology

Arthur J. Atkinson, Jr.,Darrell R. Abernethy,Charles E. Daniels,Robert Dedrick,Sanford P. Markey
Principles of Clinical Pharmacology Book PDF

Author : Arthur J. Atkinson, Jr.,Darrell R. Abernethy,Charles E. Daniels,Robert Dedrick,Sanford P. Markey
Publisher : Elsevier
Page : 568 pages
File Size : 49,9 Mb
Release : 2011-04-28
Category : Medical
ISBN : 0080466427

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Principles of Clinical Pharmacology by Arthur J. Atkinson, Jr.,Darrell R. Abernethy,Charles E. Daniels,Robert Dedrick,Sanford P. Markey Pdf

This revised second edition covers the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development, focusing on the fundamentals that underlie the clinical use and contemporary development of pharmaceuticals. Authors drawn from academia, the pharmaceutical industry and government agencies cover the spectrum of material, including pharmacokinetic practice questions, covered by the basic science section of the certifying examination offered by the American Board of Clinical Pharmacology. This unique reference is recommended by the Board as a study text and includes modules on drug discovery and development to assist students as well as practicing pharmacologists. Unique breadth of coverage ranging from drug discovery and development to individualization and quality assessment of drug therapy Unusual cohesive of presentation that stems from author participation in an ongoing popular NIH course Instructive linkage of pharmacokinetic theory and applications with provision of sample problems for self-study Wide-ranging perspective of authors drawn from the ranks of Federal agencies, academia and the pharmaceutical industry Expanded coverage of pharmacogenetics Expanded coverage of drug transporters and their role in interactions Inclusion of new material on enzyme induction mechanisms in chapters on drug metabolism and drug interactions A new chapter on drug discovery that focuses on oncologic agents Inclusion of therapeutic antibodies in chapter on biotechnology products

Good Research Practice in Non-Clinical Pharmacology and Biomedicine

Anton Bespalov,Martin C. Michel,Thomas Steckler
Good Research Practice in Non Clinical Pharmacology and Biomedicine Book PDF

Author : Anton Bespalov,Martin C. Michel,Thomas Steckler
Publisher : Springer Nature
Page : 424 pages
File Size : 54,7 Mb
Release : 2020-01-01
Category : Cardiology
ISBN : 9783030336561

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Good Research Practice in Non-Clinical Pharmacology and Biomedicine by Anton Bespalov,Martin C. Michel,Thomas Steckler Pdf

This open access book, published under a CC BY 4.0 license in the Pubmed indexed book series Handbook of Experimental Pharmacology, provides up-to-date information on best practice to improve experimental design and quality of research in non-clinical pharmacology and biomedicine.

Drug Discovery and Clinical Research

SK Gupta
Drug Discovery and Clinical Research Book PDF

Author : SK Gupta
Publisher : JP Medical Ltd
Page : 659 pages
File Size : 53,9 Mb
Release : 2011-06
Category : Medical
ISBN : 9789350252727

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Drug Discovery and Clinical Research by SK Gupta Pdf

The Drug Discovery and Clinical Research bandwagon has been joined by scientists and researchers from all fields including basic sciences, medical sciences, biophysicists, biotechnologists, statisticians, regulatory officials and many more. The joint effort and contribution from all is translating into the fast development of this multi-faceted field. At the same time, it has become challenging for all stakeholders to keep abreast with the explosion in information. The race for the finish-line leaves very little time for the researchers to update themselves and keep tabs on the latest developments in the industry. To meet these challenges, this book entitled Drug Discovery and Clinical Research has been compiled. All chapters have been written by stalwarts of the field who have their finger on the pulse of the industry. The aim of the book is to provide succinctly within one cover, an update on all aspects of this wide area. Although each of the chapter dealt here starting from drug discovery and development, clinical development, bioethics, medical devices, pharmacovigilance, data management, safety monitoring, patient recruitment, etc. are topics for full-fledged book in themselves, an effort has been made via this book to provide a bird’s eye view to readers and help them to keep abreast with the latest development despite constraints of time. It is hoped that the book will contribute to the growth of readers, which should translate into drug discovery and clinical research industry’s growth.

Clinical Pharmacy Education, Practice and Research

Dixon Thomas
Clinical Pharmacy Education Practice and Research Book PDF

Author : Dixon Thomas
Publisher : Elsevier
Page : 540 pages
File Size : 47,7 Mb
Release : 2018-11-23
Category : Business & Economics
ISBN : 9780128142776

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Clinical Pharmacy Education, Practice and Research by Dixon Thomas Pdf

Clinical Pharmacy Education, Practice and Research offers readers a solid foundation in clinical pharmacy and related sciences through contributions by 83 leading experts in the field from 25 countries. This book stresses educational approaches that empower pharmacists with patient care and research competencies. The learning objectives and writing style of the book focus on clarifying the concepts comprehensively for a pharmacist, from regular patient counseling to pharmacogenomics practice. It covers all interesting topics a pharmacist should know. This book serves as a basis to standardize and coordinate learning to practice, explaining basics and using self-learning strategies through online resources or other advanced texts. With an educational approach, it guides pharmacy students and pharmacists to learn quickly and apply. Clinical Pharmacy Education, Practice and Research provides an essential foundation for pharmacy students and pharmacists globally. Covers the core information needed for pharmacy practice courses Includes multiple case studies and practical situations with 70% focused on practical clinical pharmacology knowledge Designed for educational settings, but also useful as a refresher for advanced students and researchers

A Guide to Clinical Drug Research

A. Cohen,J. Posner
A Guide to Clinical Drug Research Book PDF

Author : A. Cohen,J. Posner
Publisher : Springer Science & Business Media
Page : 205 pages
File Size : 52,9 Mb
Release : 2013-04-17
Category : Medical
ISBN : 9789401584630

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A Guide to Clinical Drug Research by A. Cohen,J. Posner Pdf

A Guide to Clinical Drug Research provides practical advice, from the conception of an idea, planning a study and writing a protocol, through to the conduct of a study, data collection and analysis, and publication. It tells investigators what information they should expect sponsoring companies to provide, particularly when there is only limited information available about a new drug. It also explains what the company can expect of investigators, including the requirements of `good clinical practice'. Unlike other currently available texts on clinical trials and pharmaceutical medicine, A Guide to Clinical Drug Research concentrates on the needs of the practising clinician and research team. It is not restricted to drug investigation, and is relevant to all those involved in clinical research in a variety of settings. Audience: Required reading for clinical researchers and others involved as investigators in a drug project, often sponsored by a pharmaceutical company, plus agents of the sponsoring companies themselves.

Clinical Pharmacology: Current Topics and Case Studies

Markus Müller
Clinical Pharmacology Current Topics and Case Studies Book PDF

Author : Markus Müller
Publisher : Springer
Page : 405 pages
File Size : 48,7 Mb
Release : 2016-03-15
Category : Medical
ISBN : 9783319273471

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Clinical Pharmacology: Current Topics and Case Studies by Markus Müller Pdf

This revised and extended second edition focuses on current and emerging topics in drug development, their molecular mechanisms of action as well as regulatory issues. In addition, in-depth insights into clinical drug research and trial methodology are presented on the basis of concrete case studies. This updated book makes a valuable contribution to the field of Clinical Pharmacology and serves as a must-have guide for professors, researchers and advanced students from academia and pharmaceutical industry.

Career Opportunities in Clinical Drug Research

Rebecca Jane Anderson
Career Opportunities in Clinical Drug Research Book PDF

Author : Rebecca Jane Anderson
Publisher : Rebecca Anderson
Page : 288 pages
File Size : 45,9 Mb
Release : 2010
Category : Business & Economics
ISBN : 9781936113057

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Career Opportunities in Clinical Drug Research by Rebecca Jane Anderson Pdf

"It is simply amazing to me that so many of my industry coworkers stumbled upon their careers in clinical research, like I did, merely by chance. In most cases, once those opportunities were presented to us, we found fulfilling and successful careers. Undoubtedly, other eager job seekers would also find this career path attractive. If only someone would tell them about it."

Principles and Practice of Clinical Trial Medicine

Richard Chin,Bruce Y Lee
Principles and Practice of Clinical Trial Medicine Book PDF

Author : Richard Chin,Bruce Y Lee
Publisher : Elsevier
Page : 560 pages
File Size : 49,5 Mb
Release : 2008-07-25
Category : Medical
ISBN : 9780080557939

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Principles and Practice of Clinical Trial Medicine by Richard Chin,Bruce Y Lee Pdf

Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, Principles and Practice of Clinical Trial Medicine covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results. Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine Expert authorship whose experience includes running clinical trials in an academic as well as industry settings Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy

Atkinson's Principles of Clinical Pharmacology

Shiew-Mei Huang,Juan J.L. Lertora,Paolo Vicini,Arthur J. Atkinson Jr.
Atkinson s Principles of Clinical Pharmacology Book PDF

Author : Shiew-Mei Huang,Juan J.L. Lertora,Paolo Vicini,Arthur J. Atkinson Jr.
Publisher : Academic Press
Page : 764 pages
File Size : 47,6 Mb
Release : 2021-10-16
Category : Medical
ISBN : 9780128198841

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Atkinson's Principles of Clinical Pharmacology by Shiew-Mei Huang,Juan J.L. Lertora,Paolo Vicini,Arthur J. Atkinson Jr. Pdf

Atkinson’s Principles of Clinical Pharmacology, Fourth Edition is the essential reference on the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development. This well-regarded survey continues to focus on the basics of clinical pharmacology for the development, evaluation and clinical use of pharmaceutical products while also addressing the most recent advances in the field. Written by leading experts in academia, industry, clinical and regulatory settings, the fourth edition has been thoroughly updated to provide readers with an ideal reference on the wide range of important topics impacting clinical pharmacology. Presents the essential knowledge for effective practice of clinical pharmacology Includes a new chapter and extended discussion on the role of personalized and precision medicine in clinical pharmacology Offers an extensive regulatory section that addresses US and international issues and guidelines Provides extended coverage of earlier chapters on transporters, pharmacogenetics and biomarkers, along with further discussion on "Phase 0" studies (microdosing) and PBPK

Global Clinical Trials

Richard Chin,Menghis Bairu
Global Clinical Trials Book PDF

Author : Richard Chin,Menghis Bairu
Publisher : Academic Press
Page : 522 pages
File Size : 45,7 Mb
Release : 2011-05-06
Category : Science
ISBN : 012381538X

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Global Clinical Trials by Richard Chin,Menghis Bairu Pdf

This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials. Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting Case studies outline successes, failures, lessons learned and prospects for future collaboration Includes country-specific guidelines for the most utilized countries Foreword by David Feigel, former Head of CDRH at FDA