Drug Safety Evaluation

Drug Safety Evaluation

Despite the considerable number of newer antibacterials made available over the past decades, amoxicillin, alone or in combination with clavulanic acid, still accounts among the most widely used antibacterial agents. Although they are often considered ‘twin drugs’, they are different both in terms of antibacterial activities and of safety profile. It is well documented that the clavulanate comp...

Patient-reported outcomes in drug safety evaluation.

The current standard method for adverse symptom monitoring in clinical trials is staff reporting [1, 2]. This is generally conducted via a complex process of data transfer, during which clinicians interview patients and then document impressions in medical charts ad hoc; study personnel abstract these charts and convert reported symptoms to a standard lexicon such as the Common Terminology Crit...

Drug Screening and Drug Safety Evaluation by Patch Clamp Technique

Pooling, meta-analysis, and the evaluation of drug safety

BACKGROUND: The "integrated safety report" of the drug registration files submitted to health authorities usually summarizes the rates of adverse events observed for a new drug, placebo or active control drugs by pooling the safety data across the trials. Pooling consists of adding the numbers of events observed in a given treatment group across the trials and dividing the results by the total ...

Drug Safety Unscrambling Post - Approval Drug Safety Monitoring

Among the thorny issues confronting newlyconfirmed FDA Commissioner Gottlieb is the unresolved rulemaking proposal to permit generic drug manufacturers to amend safety warnings in their labels without prior FDA approval. At present, only pioneer branded manufacturers holding New Drug Applications may make such amendments to respond to newlydiscovered evidence of a reasonable association between...