Clinical pharmacology and therapeutics
-
Clin. Pharmacol. Ther. · Feb 2007
Randomized Controlled TrialClinical pharmacology of 1,4-butanediol and gamma-hydroxybutyrate after oral 1,4-butanediol administration to healthy volunteers.
1,4-Butanediol (BD) is converted to gamma-hydroxybutyrate (GHB) after ingestion, and is associated with cases of dependence, coma, and death. The pharmacology of BD after oral ingestion has not been described in humans. Eight healthy volunteers (five men) were administered 25 mg/kg BD in a single oral dose after an overnight fast in a double-blinded, placebo-controlled, crossover study. ⋯ Transient increases in mean systolic and diastolic blood pressure were observed, but other vital signs remained unchanged. BD was extensively converted to GHB after oral administration, but significant inter-individual variability in the rate of metabolism, possibly related to variants in ADH-IB, was observed. At the modest dose studied, significant clinical effects were not seen.
-
Clin. Pharmacol. Ther. · Feb 2007
Review and critique of the Institute of Medicine report "the future of drug safety".
In September 2006 an Institute of Medicine (IOM) ad hoc committee on the Assessment of the US Drug Safety System released its report entitled "The Future of Drug Safety: Promoting and Protecting the Health of the Public". The committee's report includes 25 recommendations that "will bring the strengths of the preapproval process (data, regulatory authority, organizational function and capabilities, and resources) to the postapproval phase in order to fulfill a lifecycle approach to the study, regulation, and communication about the risks and benefits of drugs." Copies of the report are available from the National Academies Press (800-624-6242), and the full text is available at http://www.nap.edu.