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Conducting biomedical research is essential in both the clinical and research areas;. It entails a series of dangers for people involved in these activities. These risks, could be biological, chemical or radiological. These risks can be mitigated or controlled with appropriate protocols and recommendations. This guide shows in a simple way, the main measures and considerations that a researcher who carries out a protocol must know and apply, in order to make a correct assessment of the risk that the activities involved in the protocol. Thus, is essential to implement measures to ensure health and safety of involved people, whether they directly participate or not in the protocol. [ABSTRACT FROM AUTHOR]

Background: Buprenorphine (BPN) is a widely used analgesic in the pediatric population, although there are few studies on the pharmacokinetics and pharmacodynamics of this drug. Objective: The objective was to characterize the pharmacokinetics of BPN after intravenous administration and analyze the effect of age, gender, weight, height, body mass index (BMI), and drug-drug interactions as covariates. Methods: Ninety-nine children (2-10 years), who underwent orthopedic surgery under regional, general, or combined anesthesia were included. Patients evaluated according to the American Society of Anesthesiologists Physical Status Classification, who received intravenous BPN 2 μg/kg were enrolled. Blood was collected from 1-240 min. Drug plasma concentrations were determined by LC-MS/MS. Population pharmacokinetic parameters were obtained with Monolix 2021R1 software. Pearson's correlation and/or ANOVA were used for statistical analysis. Results: Age was associated with changes in clearance and central compartment volume and the female gender was associated with lower intercompartmental clearance, while BMI modified clearance, central and peripheral compartment volume. Concomitant administration of BPN with fentanyl and dexamethasone produced decreases in clearance. Conclusions: The covariates of sex, age, and BMI are directly related to the increase or decrease in BPN pharmacokinetic parameters. [ABSTRACT FROM AUTHOR]