For studies involving a single dosing event, an interval of 24 h should be used before an alternative dose level is examined, to allow any acute adverse effects to be seen.
Reports have been inconsistent regarding the alcohol intake threshold at which such effects occur [ 3]: some studies report that low-moderate levels of maternal alcohol consumption have no consistent significant effect on birth outcome and fetal malformation [ 4, 5], while other studies indicate even single-dose events can result in observable deficits [ 1].
Data are limited regarding CV risks associated with short-term nonsteroidal anti-inflammatory drug use, including injectable formulations, although it has been suggested that even a single dose may increase CV adverse event (AE) risk.
Eight included studies reported adverse events for single dose data [36 40, unpublished studies].
To study the clinical efficacy and adverse events of weekly single dose of leflunomide in patients with refractory rheumatoid arthritis in comparison with conventional daily regimen.
4. To estimate the frequency of severe or haematological adverse events associated with single dose or short course PQ when it has been used for this purpose.
These were therefore the primary outcomes of interest, together with any information on time to remedication and adverse events, of a single dose of oral naproxen/naproxen sodium over 4 to 6 hours in the treatment of acute postoperative pain, from meta-analysis of randomised, double blind, placebo controlled clinical trials.
In the single dose BLM model, pulmonary fibrosis develops through sequential events after BLM administration; first in inflammation phase (≤7 days), followed by fibrosis phase (≥7 days) [ 30].
The majority of adverse events resolved with treatment delay, while a single dose reduction was required in 29% of patients and multiple reductions in only 9%.
Precursor events have typically been studied at a single dose, often eliciting a near maximal response, thus precluding benchmark-based comparisons across studies.
The amount of information (number of patients randomized) was insufficient to make any authoritative statement about adverse events, or compare the adverse event profile of rofecoxib 50 mg in single doses with other single dose analgesics.
