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Showing 1 to 12 of 60 entries
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Updating of a method for causality assessment of adverse drug reactions.

International journal of clinical pharmacology, therapy, and toxicology

Venulet J, Ciucci AG, Berneker GC.
PMID: 3781677
Int J Clin Pharmacol Ther Toxicol. 1986 Oct;24(10):559-68.

The paper represents an update of a method of standardized assessment of causality that was published in 1980. Because of experience that was gained in the meantime, weighting of certain types of information was modified and several weighting tables...

Erratum.

International journal of clinical pharmacology and therapeutics

[No authors listed]
PMID: 26229998
Int J Clin Pharmacol Ther. 2015 May;53(5):414.

No abstract available.

The responsibility for the study protocol in a drug trial.

International journal of clinical pharmacology, therapy, and toxicology

Schmidt R.
PMID: 3997301
Int J Clin Pharmacol Ther Toxicol. 1985 Mar;23(3):158-60.

A well-designed protocol is an essential part of any clinical trial. In a drug trial it should be the result of a joint effort involving the physician performing the trial at the clinic and the specialist in the drug...

Necessity and requirements of bridging studies and their present status in Japan.

International journal of clinical pharmacology and therapeutics

Naito C.
PMID: 10706195
Int J Clin Pharmacol Ther. 2000 Feb;38(2):80-6. doi: 10.5414/cpp38080.

The mainstays of the harmonized final document about ethnic factors in the acceptability of foreign clinical data include a complete clinical data package and a bridging study (for efficacy and/or for safety). A clinical data package that meets all...

COVID 19: Pandemic assessment and management using Incidence.

International journal of clinical pharmacology and therapeutics

Braun P, Woodcock BG.
PMID: 34854373
Int J Clin Pharmacol Ther. 2021 Dec 02; doi: 10.5414/CPP60001. Epub 2021 Dec 02.

No abstract available.

Comparative efficacy and safety of topiroxostat at different dosages in hyperuricemic patients with or without gout: A network meta-analysis of randomized controlled trials.

International journal of clinical pharmacology and therapeutics

Lee YH, Song GG.
PMID: 34889733
Int J Clin Pharmacol Ther. 2021 Dec 10; doi: 10.5414/CP204108. Epub 2021 Dec 10.

OBJECTIVE: We aimed to assess the relative efficacy and safety of topiroxostat at different dosages in hyperuricemic patients with or without gout.MATERIALS AND METHODS: A Bayesian network meta-analysis was performed to combine direct and indirect evidence from randomized controlled...

Drug-induced, mixed-type hepatitis following ingestion of .

International journal of clinical pharmacology and therapeutics

Thurian D, Montani M, Stickel F.
PMID: 34889735
Int J Clin Pharmacol Ther. 2021 Dec 10; doi: 10.5414/CP204139. Epub 2021 Dec 10.

The use of herbal and dietary supplements is increasing worldwide. Consumers consider it as a natural, and therefore safe and healthy alternative to conventional synthetic drugs and do not expect adverse effects. However, numerous herbal and dietary supplements have...

Randomized, double-blind, two-way crossover bioequivalence and adhesion study, in healthy women, of a transdermal contraceptive patch with a newly sourced adhesive component at the end of shelf life vs. the EVRA patch at the beginning of shelf life.

International journal of clinical pharmacology and therapeutics

Sanga M, Vaughan S, Nangosyah J, Scholz V, Fonseca S.
PMID: 34779392
Int J Clin Pharmacol Ther. 2021 Nov 15; doi: 10.5414/CP204034. Epub 2021 Nov 15.

OBJECTIVE: Evaluate bioequivalence, based on norelgestromin (NGMN) and ethinyl estradiol (EE) plasma concentrations, and adhesion of a transdermal contraceptive patch containing a newly sourced adhesive component (test) at end of shelf life (EOSL) vs. the marketed EVRA patch (reference)...

Off-label prescribing during pregnancy in France: the NéHaVi cohort
.

International journal of clinical pharmacology and therapeutics

Laroche ML, Blin A, Coubret A, Grau M, Roux B, Aubard Y.
PMID: 31933473
Int J Clin Pharmacol Ther. 2020 Apr;58(4):198-208. doi: 10.5414/CP203578.

OBJECTIVE: To describe the off-label medication use in a cohort of pregnant women.MATERIAL AND METHODS: We performed a multicenter prospective longitudinal observational study in the Haute-Vienne department (France) called the NéHaVi cohort ("Né en Haute-Vienne" meaning "born in Haute-Vienne")....

Predictions for the COVID-19 pandemic in Germany using the modified Bateman SIZ model.

International journal of clinical pharmacology and therapeutics

Braun P, Haffner S, Aguirre Davila L, Braun J, Woodcock BG.
PMID: 32800093
Int J Clin Pharmacol Ther. 2020 Sep;58(9):467-474. doi: 10.5414/CP203868.

AIMS OF THE STUDY: To obtain predictions for the course of the COVID-19 pandemic in Germany using the modified Bateman SIZ model and input variables based on the status quo in July 2020. To predict the effect of a...

Association of gynecomastia with antidiabetic medications in older adults: data mining from different national pharmacovigilance databases.

International journal of clinical pharmacology and therapeutics

Ohyama K, Tanaka H, Shindo J, Shibayama M, Iwata M, Hori Y.
PMID: 34622771
Int J Clin Pharmacol Ther. 2021 Oct 08; doi: 10.5414/CP204066. Epub 2021 Oct 08.

OBJECTIVE: Gynecomastia is a benign proliferation of the glandular breast tissue in men and is generally caused by a decrease in androgen and an increase in estrogen. Diabetes has been reported to be a risk factor for lowering androgen...

Comparative efficacy and safety of topiroxostat at different dosages in hyperuricemic patients with or without gout: A network meta-analysis of randomized controlled trials.

International journal of clinical pharmacology and therapeutics

Lee YH, Song GG.
PMID: 34889733
Int J Clin Pharmacol Ther. 2021 Dec 10; doi: 10.5414/CP204108. Epub 2021 Dec 10.

OBJECTIVE: We aimed to assess the relative efficacy and safety of topiroxostat at different dosages in hyperuricemic patients with or without gout.MATERIALS AND METHODS: A Bayesian network meta-analysis was performed to combine direct and indirect evidence from randomized controlled...

Showing 1 to 12 of 60 entries