Results 181 to 190 of about 25,533 (219)

A statistical methodology for postmarketing surveillance of adverse drug reaction reports.

Statistics in Medicine, 1988
This paper presents a statistically optimal exact hypothesis testing procedure for detecting changes in sales adjusted adverse drug reaction (ADR) rates between historical and current periods, with a computer program that implements this test appended ...
P. Norwood, A. Sampson
semanticscholar   +1 more source

Complementary hypotheses in safety surveillance

, 2020
Postmarketing safety surveillance studies address two actionable questions: (1) Is the test product riskier than a standard? (2) Is the risk associated with the test product within some tolerable margin by comparison to the standard?
A. Walker
semanticscholar   +1 more source

Postmarket surveillance of natural health products in Canada: clinical and federal regulatory perspectivesThis article is one of a selection of papers published in this special issue (part 1 of 2) on the Safety and Efficacy of Natural Health Products.

Canadian Journal of Physiology and Pharmacology, 2007
Postmarket surveillance, particularly adverse reactions (ARs), forms an integral part of the ongoing safety evaluation for natural health products (NHPs). ARs can be related to many factors, including inherent toxicity, misuse, hypersensitivity, NHP–drug interactions, or product quality.
openaire   +3 more sources

Safety of oral terbinafine : Results of a postmarketing surveillance study in 25 884 Patients

, 1997
Objective: To broaden the safety database for oral terbinafine by determining the incidence of adverse events, particularly rare risks, that accompany its uncontrolled use in actual clinical practice.
M. Hall, C. Monka, P. Krupp, D. O'Sullivan   +3 more
semanticscholar   +1 more source

1999 annual report of the American Association of Poison Control Centers Toxic Exposure Surveillance System.

American Journal of Emergency Medicine, 2000
Toxic Exposure Surveillance System (TESS) data are compiled by the American Association of Poison Control Centers (AAPCC) in cooperation with the majority of US poison centers.
T. Litovitz, W. Klein‐Schwartz, S. White, D. J. Cobaugh, J. Youniss, A. Drab, B. E. Benson   +6 more
semanticscholar   +1 more source

Development and Application of a Data-Driven Signal Detection Method for Surveillance of Adverse Event Variability Across Manufacturing Lots of Biologics

Drug Safety, 2023
Joshua T Wilde, S. Springs, J. Wolfrum, R. Levi   +3 more
semanticscholar   +1 more source

Effectiveness and Safety of Matrix-Associated Autologous Chondrocyte Implantation for the Treatment of Articular Cartilage Defects: A Real-World Data Analysis in Japan

American Journal of Sports Medicine
Background: The effectiveness and safety of matrix-associated autologous chondrocyte implantation with an autologous periosteal flap (pMACI) remain unclear.
Yuji Uchio, Ryosuke Kuroda, Yasuo Niki, Katsura Sugawara, Yasuyuki Ishibashi   +4 more
semanticscholar   +1 more source

Phase IV Studies: What Clinicians Need to Know!

Journal of Association of Physicians of India
Phase IV trials, also known as postmarketing safety and efficacy studies and postmarketing surveillance (PMS) studies, occur after a drug or medical device has received regulatory approval and is available in the market.
Abhijit Trailokya, Ambrish Srivastava, Q. Mukaddam, S. Chaudhry, Kamlesh Patel, S. Suryawanshi, Manoj Naik   +6 more
semanticscholar   +1 more source

Postmarket surveillance and returned product analysis: Success but not transparency

Heart Rhythm, 2013
Robert M. Califf, Jonathan P. Piccini
openaire   +3 more sources

Evaluation of Postmarketing Reports from Industry-Sponsored Programs in Drug Safety Surveillance

Drug Safety, 2018
L. Harinstein, Dipti Kalra, C. Kortepeter, M. Muñoz, E. Wu, G. D. Dal Pan   +5 more
semanticscholar   +1 more source