Cross-sectional survey of underreported violence experienced by adolescents: a study from Indonesia.

BACKGROUND: Global studies on adolescent victims of violence require serious attention due to the possibility that underreported cases may be higher than official records indicate. Since Indonesia expects to witness a demographic bonus, extensive research is needed to strengthen early detection, case handling, and prevention. Here, we report the outcomes of a survey on physical, verbal, and sexual violence experienced by adolescents in West Java, an Indonesian province inhabited by 18% of the country's total population. METHODS: We conducted a cross-sectional survey in 2017 using the International Society for the Prevention of Child Abuse and Neglect (ISPCAN) Child Abuse Screening Tool for Children (ICAST-C) questionnaire for detecting child abuse; an expert panel translated, simplified, and validated it based on a theoretical framework that combines paediatrics, public health, and medicolegal perspectives. We aimed to cover a large sample size and explore three types of violence (physical, verbal, and sexual) that have high evidentiary value in the forensic context. The respondents were adolescents in the first and second grades of middle school (12 to 14 years old) and high school (15 to 17 years old) in seven cities/municipalities in the province, selected through several stages of simple random sampling (N = 3452). We analysed the samples through univariate (percentage), odds ratio (OR), comparison, correlation, and correspondence analyses. RESULTS: The results showed that 78.7% of the adolescents experienced violence in 2017, comprising those who encountered at least one incidence of physical violence (43.1%), verbal violence (12.2%), and sexual violence (4.5%). Data overlap includes 14.3% who experienced one type of violence in 2017, 7.4% who experienced two forms of violence, and 1.4% who underwent all three kinds of violence. The offenders were mainly adolescents across all types of violence, except for being forced to engage in sexual intercourse. Several victims of sexual violence did not state who the offenders were. Further, several characteristics showed a higher chance of experiencing violence than other characteristics, especially for adolescents who were still in middle school and those who lived only with their mothers. Correspondence analysis suggested subtle differences between characteristics. CONCLUSION: We expect this study to help identify risk and protective factors that are essential to strengthening early detection efforts, decisive medicolegal examinations, case handling, and policy-making.

Bioequivalence study of two risedronate sodium film-coated tablet formulations in healthy volunteers.

The present study was performed to compare the bioavailability of 2 risedronate sodium 35 mg film-coated tablet formulations (test formulation and reference formulation). Prior to the present study, in vitro comparative dissolution test has been conducted for test and reference formulations. Dissolution profiles shown that more than 85% of the drug is dissolved within 15 min at pH 1.2, pH 4.5, and pH 6.8.This study was a randomized, single-blind, 2-period, 2-sequence cross-over study which included 48 evaluable healthy adult male and female subjects under fasting condition. In each of the 2 study periods (separated by a washout of 3 weeks) a single dose of test or reference drug was administered. The pharmacokinetic parameters assessed in this study were cumulative urinary excretion from drug administration to 72 h (Ae72h) and maximum urine excretion rate (dAe/dtmax). These parameters were determined from urine concentrations of risedronate and urine volume. Urinary concentrations of the drug were determined by high performance liquid chromatographic method with UV detector.The geometric mean ratios (90% CI) of the test drug/reference drug for risedronate were 106.60% (92.34-123.07%) for Ae72h and 104.75% (88.86-123.47%) for dA/dtmax. The geometric mean ratios calculated for Ae72h and dA/dtmax of risedronate were within the bioequivalence range (80.00-125.00% for Ae72h and dA/dtmax). It was concluded that the 2 risedronate sodium film-coated tablets (test and reference drugs) were bioequivalent.

Bioequivalence study of 2 formulations of film-coated tablets containing a fixed dose combination of bisoprolol fumarate 5 mg and hydrochlorothiazide 6.25 mg in healthy subjects.

BACKGROUND: The present study was conducted to compare the bioavailability of 2 formulations of fixed-dose combination of bisoprolol fumarate 5 mg and hydrochlorotiazide (HCT) 6.25 mg film-coated tablet (test and reference formulations). METHODS: This study was a randomized, single-blind, 2-period, 2-sequence cross-over study which included 18 healthy adult male and female subjects under fasting condition. The pharmacokinetic parameters, AUCt, AUCinf, Cmax, tmax, and t½ were determined based on the concentrations of bisoprolol (CAS 66722-44-9) and HCT (CAS 58-93-5), using ultra-performance liquid chromatography with tandem mass spectrometer detector (UPLC-MS/MS). In each of the 2 study periods (with a washout of 1 week) a single dose of test or reference product was administered. RESULTS: The geometric mean ratios (90% CI) of the test drug/reference drug for bisoprolol were 97.22% (93.75-100.83%) for AUCt(0-48), 97.20% (93.97-100.54%) for AUCinf, and 100.36% (93.83-107.34%) for Cmax; while those for HCT were 93.22% (84.72-102.57%), 93.39% (85.43-102.10%) and 99.39% (85.45-115.61%), for AUCt(0-24), AUCinf, and Cmax, respectively. The differences between the test and reference drug products for tmax values of bisoprolol as well as t½ values of both bisoprolol and hydrochlorothiazide were not statistically significant; yet, the difference was statistically significant for the tmax values of hydrochlorothiazide. There was no adverse event encountered during this bioequivalence test. MAJOR CONCLUSION: It was concluded that the 2 formulations of fixed dose combination of bisoprolol fumarate 5 mg and hydrochlorotiazide (HCT) 6.25 mg film-coated tablet (the test and reference products) were bioequivalent.