FDA's Regulation of the New Drug Versed

FDA's Regulation of the New Drug Versed
Author: United States. Congress. House. Committee on Government Operations. Human Resources and Intergovernmental Relations Subcommittee
Publisher:
Total Pages: 610
Release: 1988
Genre: Anesthetics
ISBN:

Versed

Versed
Author: Rae Armantrout
Publisher: Wesleyan University Press
Total Pages: 136
Release: 2010-08
Genre: Poetry
ISBN: 0819570915

"A collection of poetry organized in two sections. The first section, "Versed," play with vice and versa, the perversity of human consciousness. They flirt with error and delusion, skating on a thin ice that inevitably cracks. The second section, "Dark Matter," alludes to more than the unseen substance thought to make up the majority of mass in the universe. The invisible and unknowable are confronted directly as the author's experience with cancer marks these poems with a new austerity, shot through with her signature wit and stark unsentimental thinking."--Résumé de l'éditeur.

The Therapeutic Nightmare

The Therapeutic Nightmare
Author: John Abraham
Publisher: Routledge
Total Pages: 197
Release: 2014-03-18
Genre: Law
ISBN: 1134195745

How do drugs get to the market? What controls are there and what procedures for monitoring their effects? And how adequate are the regulators in protecting public health when new drugs have serious side effects? The Therapeutic Nightmare tells the story of the sleeping pill Halcion - a story which is far from over. First marketed in the 1970s, Halcion has been taken by millions of patients around the world. For many years it has been associated with serious adverse effects such as amnesia, hallucinations, aggression and, in extreme cases, homicide. Thirteen years after its first release, it was banned by the British government. It remains on sale in the United States and many other countries. This book explains why patients have come to be exposed to Halcion's risks and examines the corporate interests of the manufacturers, the professional interests of the scientists and medical researchers and the interests of patients in safe and effective medication. It reveals how these contending forces shape the regulatory decision-making process about drug safety. As the number of new drugs and health products grows, a major challenge facing regulators and the medical profession is how to put the interests of public health decisively and consistently above the commercial interests of the drugs industry, while becoming more accountable to patient and consumer organizations.

Pharmacometrics

Pharmacometrics
Author: Ene I. Ette
Publisher: John Wiley & Sons
Total Pages: 1236
Release: 2013-03-14
Genre: Medical
ISBN: 1118679512

Pharmacometrics is the science of interpreting and describing pharmacology in a quantitative fashion. The pharmaceutical industry is integrating pharmacometrics into its drug development program, but there is a lack of and need for experienced pharmacometricians since fewer and fewer academic programs exist to train them. Pharmacometrics: The Science of Quantitative Pharmacology lays out the science of pharmacometrics and its application to drug development, evaluation, and patient pharmacotherapy, providing a comprehensive set of tools for the training and development of pharmacometricians. Edited and written by key leaders in the field, this flagship text on pharmacometrics: Integrates theory and practice to let the reader apply principles and concepts. Provides a comprehensive set of tools for training and developing expertise in the pharmacometric field. Is unique in including computer code information with the examples. This volume is an invaluable resource for all pharmacometricians, statisticians, teachers, graduate and undergraduate students in academia, industry, and regulatory agencies.

Product Liability Standards

Product Liability Standards
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Commerce, Consumer Protection, and Competitiveness
Publisher:
Total Pages: 510
Release: 1994
Genre: Business & Economics
ISBN:

Framing Opioid Prescribing Guidelines for Acute Pain

Framing Opioid Prescribing Guidelines for Acute Pain
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 223
Release: 2020-03-20
Genre: Medical
ISBN: 030949687X

The opioid overdose epidemic combined with the need to reduce the burden of acute pain poses a public health challenge. To address how evidence-based clinical practice guidelines for prescribing opioids for acute pain might help meet this challenge, Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence develops a framework to evaluate existing clinical practice guidelines for prescribing opioids for acute pain indications, recommends indications for which new evidence-based guidelines should be developed, and recommends a future research agenda to inform and enable specialty organizations to develop and disseminate evidence-based clinical practice guidelines for prescribing opioids to treat acute pain indications. The recommendations of this study will assist professional societies, health care organizations, and local, state, and national agencies to develop clinical practice guidelines for opioid prescribing for acute pain. Such a framework could inform the development of opioid prescribing guidelines and ensure systematic and standardized methods for evaluating evidence, translating knowledge, and formulating recommendations for practice.