Drug Safety Data

Drug Safety Data

The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for premarketing risk assessment.

Author: Michael J. Klepper

Publisher: Jones & Bartlett Learning

ISBN: 0763769126

Category: Medical

Page: 312

View: 649

Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices. Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment. With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is the definitive guide to drug safety data analysis and reporting. Key features include: * Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports * Pragmatic tips...and mistakes to avoid * Simple explanations of what safety data are collected, and what the data mean * Practical approaches to determining a drug effect and understanding its clinical significance * Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical * Examples of user-friendly data displays that enhance safety signal identification * Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting * Relevant material for the required training of drug safety/pharmacovigilance professionals * SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)
Categories: Medical

Sessional Papers

Sessional Papers

the new Committee on Safety of Medicines, recommended that it should reflect a similar range of skills, and that a number of members of the Committee on Safety of Drugs, including the Chairman, Professor E. F. Scowen, should be included ...

Author: Great Britain. Parliament. House of Commons

Publisher:

ISBN: MINN:31951D02550647W

Category: Great Britain

Page:

View: 738

Categories: Great Britain

Stephens Detection and Evaluation of Adverse Drug Reactions

Stephens  Detection and Evaluation of Adverse Drug Reactions

Praise for previous editions "This book presents a comprehensive and wide-ranging overview of the science of pharmacovigilance.

Author: John Talbot

Publisher: John Wiley & Sons

ISBN: 9781119952107

Category: Medical

Page: 648

View: 555

The detection and evaluation of adverse drug reactions is crucial for understanding the safety of medicines and for preventing harm in patients. Not only is it necessary to detect new adverse drug reactions, but the principles and practice of pharmacovigilance apply to the surveillance of a wide range of medicinal products. Stephens' Detection and Evaluation of Adverse Drug Reactions provides a comprehensive review of all aspects of adverse drug reactions throughout the life cycle of a medicine, from toxicology and clinical trials through to pharmacovigilance, risk management, and legal and regulatory requirements. It also covers the safety of biotherapeutics and vaccines and includes new chapters on pharmacogenetics, proactive risk management, societal considerations, and the safety of drugs used in oncology and herbal medicines. This sixth edition of the classic text on drug safety is an authoritative reference text for all those who work in pharmacovigilance or have an interest in adverse drug reactions, whether in regulatory authorities, pharmaceutical companies, or academia. Praise for previous editions "This book presents a comprehensive and wide-ranging overview of the science of pharmacovigilance. For those entering or already experienced in the pharmaceutical sciences, this is an essential work.” - from a review in E-STREAMS "...a key text in the area of pharmacovigilance...extensively referenced and well-written...a valuable resource..." - from a review in The Pharmaceutical Journal
Categories: Medical

Parliamentary Debates Hansard

Parliamentary Debates  Hansard

KENNETH CLARKE Pyridoxine Mr. Ashley asked the Secretary of State for Social Services if there have been any yellow card reports sent to the Committee on Safety of Medicines regarding adverse reactions to vitamin B6, pyridoxine.

Author: Great Britain. Parliament. House of Commons

Publisher:

ISBN: UIUC:30112118734141

Category: Great Britain

Page:

View: 712

Contains debates from the 2d session of the 48th Parliament through the session of the Parliament.
Categories: Great Britain

Medication Safety

Medication Safety

Medication safety is the most challenging goal for pharmacy practice and patient safety professionals in all health care facilities.

Author: Henri Richard Manasse

Publisher: Amer Soc of Health System

ISBN: UOM:39015060994848

Category: Medical

Page: 380

View: 932

Medication safety is the most challenging goal for pharmacy practice and patient safety professionals in all health care facilities.
Categories: Medical

Specialised Pharmaceutical Formulation

Specialised Pharmaceutical Formulation

8.2.1 European Medicines Agency (EMA) The European Medicines Agency is the agency responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. They play a role in facilitating the development of ...

Author: Geoffrey D Tovey

Publisher: Royal Society of Chemistry

ISBN: 9781839165610

Category: Science

Page: 338

View: 957

Formulation is a key step in the drug design process, where the active drug is combined with other substances that maximise the therapeutic potential, safety, and stability of the final medicinal product. Regulatory and quality demands, in addition to advances in processing technologies, result in growing challenges as well as possibilities for the field. Following on from Pharmaceutical Formulation, which covered traditional dosage forms such as tablets and capsules, this volume expands upon those formulations to cover a more diverse range of less common dosage forms. Novel routes of administration are covered from inhalational, dermal and transdermal formulations to ocular, oral suspensions, vaccines and nanoparticle drug delivery. The methods through which these formulations are processed and manufactured is also covered, providing essential knowledge to ensure quality, efficiency, and acceptable costing. Specialised Pharmaceutical Formulation is an essential, up to date resource for students and researchers working in academia and in the pharmaceutical industry and will equip readers with the ability to effectively and reliably produce products which can be approved, manufactured and made available to administer to patients.
Categories: Science

Ethical and Scientific Issues in Studying the Safety of Approved Drugs

Ethical and Scientific Issues in Studying the Safety of Approved Drugs

The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions.

Author: Institute of Medicine

Publisher: National Academies Press

ISBN: 9780309218139

Category: Medical

Page: 292

View: 113

An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.
Categories: Medical