Results 171 to 180 of about 13,126 (223)

Characteristics and follow‐up of postmarketing studies of conditionally authorized medicines in the EU

British Journal of Clinical Pharmacology, 2016
Aim: The aim of the present study was to provide an insight into the characteristics and follow-up of postmarketing studies of medicines that were conditionally authorized in the European Union (EU).
Jarno Hoekman, Aukje K Mantel-Teeuwisse
exaly   +2 more sources

Tocilizumab in rheumatoid arthritis: A case study of safety evaluations of a large postmarketing data set from multiple data sources

Seminars in Arthritis and Rheumatism, 2015
ObjectivesTo evaluate the magnitude of serious adverse events (SAEs) observed in postmarketing reports of tocilizumab (TCZ) for rheumatoid arthritis (RA) in relation to SAEs observed in TCZ clinical trials and external epidemiology data.MethodsA total of
, , Samy Suissa
exaly   +2 more sources

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Postmarketing Surveillance

International Journal of Pharmaceutical Medicine, 2005
The postmarketing monitoring and evaluation of the safety and effectiveness of all medicines is essential. The patterns of use, effectiveness and safety of a drug in general use may be substantially different to that in clinical trials due to differences in prescribing and patient groups; differences include the limited number of patients in studies ...
Sanath Hegde, Nithya J. Gogtay, Nilima A. Kshirsagar   +2 more
openaire   +1 more source

Techniques of Postmarketing Surveillance

Medical Toxicology, 1986
While there are many systems available for postmarketing surveillance today, none is ideal for every situation. Recent progress has been made through computerised data bases which allows for rapid identification of patients with diseases or drugs of interest. Careful planning, with attention to the relative strengths and weaknesses of each, will permit
J L, Carson, B L, Strom
openaire   +2 more sources

Postmarketing surveillance of food additives

Regulatory Toxicology and Pharmacology, 1994
Postmarketing surveillance of consumption and of anecdotal reports of adverse health effects has been recognized by a number of regulatory authorities as a potentially useful method to provide further assurance of the safety of new food additives. Surveillance of consumption is used to estimate more reliably actual consumption levels relative to the ...
H H, Butchko, C, Tschanz, F N, Kotsonis
openaire   +2 more sources

New approaches to postmarketing surveillance

Psychopharmacology, 1986
As part of a large-scale ongoing project exploring new pharmacy-based methods of postmarketing surveillance, we are comparing a patient-initiated monitoring system to a staff-initiated approach. Here we report data only from staff-initiated, computer-directed telephone interviews with 231 outpatients approximately 2 weeks after they had been prescribed
S, Fisher, S G, Bryant, R M, Kluge
openaire   +2 more sources

Assessing risk in postmarketing surveillance

Journal of Biopharmaceutical Statistics, 1991
We need to find some way to assess the probability of risk for individuals taking medications for a prolonged period of time either singly or, as is usually more likely, in combinations. It is not possible to perform detailed, controlled studies for all combinations of drugs, not even those most commonly administered.
P B, Cerrito, J C, Cerrito
openaire   +2 more sources

Dabigatran and Postmarketing Reports of Bleeding

New England Journal of Medicine, 2013
Serious and fatal bleeding events associated with use of the anticoagulant dabigatran have been reported. The FDA used the Mini-Sentinel database to determine that the actual rates of bleeding events were not higher with dabigatran than with warfarin.
Mary Ross, Southworth, Marsha E, Reichman, Ellis F, Unger   +2 more
openaire   +2 more sources

Postmarketing Experience with Topiramate and Cognition

Epilepsia, 2001
Summary: Ideal antiepileptic drugs (AEDs) are designed to stop seizures with limited central nervous system (CNS) side effects. However, CNS‐related treatment‐emergent adverse events (TEAEs) often occur in patients receiving AEDs. Topiramate (TPM) is an AED proven to be safe and effective as adjunctive treatment for epilepsy patients with partial ...
W O, Tatum, J A, French, E, Faught, G L, Morris, J, Liporace, A, Kanner, S L, Goff, L, Winters, A, Fix   +8 more
openaire   +2 more sources

Postmarketing studies of drug safety

BMJ, 2011
A European initiative could help bring more transparency and rigour to ...
Sebastian, Schneeweiss, Jerry, Avorn
openaire   +2 more sources