Results 161 to 170 of about 13,126 (223)

Postmarketing Surveillance -- Lack of Vigilance, Lack of Trust

open access: yes, 2004
Fontanarosa, Phil B.   +2 more
core  

Postmarketing Surveillance Methodologies

open access: yesDrug Intelligence & Clinical Pharmacy, 1988
This article describes and discusses the strengths and limitations of the major pharmacoepidemiologic methodologies employed in postmarketing drug surveillance and describes the current status of the U.S. surveillance system. The main methodologies employed in postmarketing drug surveillance include controlled clinical trials, observational ...
Stanley A. Edlavitch
openaire   +3 more sources

Review of Transporter‐Related Postmarketing Requirement or Postmarketing Commitment Studies

Journal of Clinical Pharmacology, 2016
AbstractThe objectives of this report are to summarize the content and status of transporter‐related postmarketing requirement (PMR)/postmarketing commitment (PMC) studies in new drug applications (NDAs) approved by the U.S. Food and Drug Administration (FDA) and to discuss the reasons for requesting such studies and the impact of PMR/PMC study results
Ying, Fan   +3 more
exaly   +3 more sources

Postmarketing surveillance for drug abuse

Drug and Alcohol Dependence, 2003
Assessing actual abuse of prescribed medications requires postmarketing surveillance. In this article we discuss general systems of postmarketing surveillance that exist as of the end of 2002 in the United States and two medication-specific surveillance systems that were devised and tested.
Cynthia L Arfken, Theodore J Cicero
exaly   +3 more sources

Famotidine: Postmarketing Clinical Experience

Scandinavian Journal of Gastroenterology, 1987
A postmarketing survey of famotidine usage (phase IV survey) tracked 6346 patients at 602 locations from August 1985 to April 1986. Through the survey, the efficacy and the safety of famotidine were studied. The patients included 4618 cases of peptic ulcer, 106 cases of reflux esophagitis, 1006 cases of upper gastrointestinal tract bleeding, 343 cases ...
K Saigenji, H Fukutomi
exaly   +3 more sources

Postmarketing Surveillance

2011
Postmarketing drug surveillance refers to the monitoring of drugs once they reach the market after clinical trials. It evaluates drugs taken by individuals under a wide range of circumstances over an extended period of time. Such surveillance is much more likely to detect previously unrecognized positive or negative effects that may be associated with ...
Vera, Vlahović-Palčevski   +1 more
  +5 more sources

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