Principles of Good Clinical Practice PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Principles of Good Clinical Practice PDF full book. Access full book title Principles of Good Clinical Practice by Michael J. McGraw. Download full books in PDF and EPUB format.
Author: Michael J. McGraw
Publisher: Pharmaceutical Press
ISBN: 0853697906
Category : Business & Economics
Languages : en
Pages : 273
Get Book Here
Book Description
Part of "RPS Pharmacy Business Administration Series", this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights.
Author: Michael J. McGraw
Publisher: Pharmaceutical Press
ISBN: 0853697906
Category : Business & Economics
Languages : en
Pages : 273
Get Book Here
Book Description
Part of "RPS Pharmacy Business Administration Series", this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights.
Author: Cemal Cingi
Publisher: Springer
ISBN: 3319443445
Category : Medical
Languages : en
Pages : 243
Get Book Here
Book Description
This brand-new book offers a reference guide to understanding and applying the rules for properly conducting clinical trials to meet the international quality standard – Good Clinical Practice – provided by the International Conference on Harmonization (ICH). The work offers an updated perspective on the clinical research landscape within the context of the clinical trial regulatory frameworks in Europe and the USA. In addition to providing a historical review and a detailed definition of GPC regulations, it includes step-by-step explanations of all the requirements that researchers should bear in mind when designing and performing new trials. Further topics covered include: ethics of clinical research; the drug development process and evolution of regulations; investigator and sponsor responsibilities; and clinical trial protocols. Written by clinicians for clinicians, the book represents a valuable read also for researchers, pharmacists and all professionals involved in applications to the ethic committees, whose approval is required for new clinical studies.
Author: DAVID. HUTCHINSON
Publisher:
ISBN: 9781912055180
Category :
Languages : en
Pages : 70
Get Book Here
Book Description
Author: MARK. ELSLEY
Publisher:
ISBN: 9781912055210
Category :
Languages : en
Pages : 46
Get Book Here
Book Description
Author: Vera Mihajlovic-Madzarevic
Publisher: John Wiley & Sons
ISBN: 0470920882
Category : Medical
Languages : en
Pages : 186
Get Book Here
Book Description
A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals. Among the topics discussed: Good Clinical Practices and therapeutic product development in clinical research The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee The roles and responsibilities of the clinical trial investigator The inspection preparation The Audit Report and the Form 483 Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030921646X
Category : Medical
Languages : en
Pages : 217
Get Book Here
Book Description
Advances in medical, biomedical and health services research have reduced the level of uncertainty in clinical practice. Clinical practice guidelines (CPGs) complement this progress by establishing standards of care backed by strong scientific evidence. CPGs are statements that include recommendations intended to optimize patient care. These statements are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options. Clinical Practice Guidelines We Can Trust examines the current state of clinical practice guidelines and how they can be improved to enhance healthcare quality and patient outcomes. Clinical practice guidelines now are ubiquitous in our healthcare system. The Guidelines International Network (GIN) database currently lists more than 3,700 guidelines from 39 countries. Developing guidelines presents a number of challenges including lack of transparent methodological practices, difficulty reconciling conflicting guidelines, and conflicts of interest. Clinical Practice Guidelines We Can Trust explores questions surrounding the quality of CPG development processes and the establishment of standards. It proposes eight standards for developing trustworthy clinical practice guidelines emphasizing transparency; management of conflict of interest ; systematic review-guideline development intersection; establishing evidence foundations for and rating strength of guideline recommendations; articulation of recommendations; external review; and updating. Clinical Practice Guidelines We Can Trust shows how clinical practice guidelines can enhance clinician and patient decision-making by translating complex scientific research findings into recommendations for clinical practice that are relevant to the individual patient encounter, instead of implementing a one size fits all approach to patient care. This book contains information directly related to the work of the Agency for Healthcare Research and Quality (AHRQ), as well as various Congressional staff and policymakers. It is a vital resource for medical specialty societies, disease advocacy groups, health professionals, private and international organizations that develop or use clinical practice guidelines, consumers, clinicians, and payers.
Author: Philip Carson
Publisher: Royal Society of Chemistry
ISBN: 1847557724
Category : Science
Languages : en
Pages : 657
Get Book Here
Book Description
Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.
Author:
Publisher: Stationery Office (U.K.)
ISBN: 9780117081079
Category : Clinical medicine
Languages : en
Pages : 0
Get Book Here
Book Description
Efforts to control atmospheric accumulations of greenhouse gases that threaten to heat up the planet are in their infancy. Although the IMF is not an environmental organization, environmental issues matter for the organization's mission when they have major implications for macroeconomic performance and fiscal policy. Climate change clearly passes both these tests. This volume provides practical guidelines for the design of fiscal policies (carbon taxes and emissions trading systems with allowance auctions) to reduce greenhouse gases. Not only are these instruments potentially the most effective at exploiting emission reduction opportunities in the near and longer term, but they can also generate for many countries a valuable new source of government revenue. The chapters, written by leading experts, explain the case for fiscal policies over other approaches; how these policies can be implemented; reasonable levels for emissions prices; policies for the forest sector; appropriate polic
Author: DAVID. HUTCHINSON
Publisher:
ISBN: 9781912055579
Category :
Languages : en
Pages :
Get Book Here
Book Description
Author: Jeannette M. Potts
Publisher: Springer Science & Business Media
ISBN: 1627030921
Category : Medical
Languages : en
Pages : 314
Get Book Here
Book Description
Extensively revised and updated, the second edition of Essential Urology: A Guide to Clinical Practice provides support to primary care physicians through its review of common genitourinary problems. This edition continues to provide the primary care physician with tools to better recognize urological diseases as well as updated management strategies for these disorders. To enhance the theme of comprehensive care and family medicine, the volume is formatted according to the life cycle and the urological challenges, which may be detected and diagnosed by primary care physicians respective of the patient’s stage in life, beginning with pregnancy and in utero diagnoses. Pediatric themes such as infection and voiding dysfunctions are followed by adult urological topics ranging from prostate diseases, nephrolithiasis, overactive bladder syndromes, incontinence and urological cancer screening. Three new chapters are added addressing male infertility/andrology and the growing demand for integrative and alternative medical care of urologic patients, as well as commonly encountered dermatological problems in the genital area. Essential Urology: A Guide to Clinical Practice, Second Edition is extremely comprehensive and yet, very accessible. It is authored by experts representing the spectrum of urological subspecialties, further enhancing the value of this unique work.
