A Two ‐Sequence, Four‐Period, Crossover, Replicate Study to Demonstrate Bioequivalence of Warfarin Sodium Tablet in Healthy Chinese Subjects Under Fasting and Fed Conditions
AbstractWarfarin is a narrow therapeutic index anticoagulant drug, and several generic formulations have been approved worldwide. However, there has been no report evaluating the bioequivalence of warfarin sodium according to US Food and Drug Administration draft guidance. We designed a 2 ‐sequence and 4‐period crossover study to compare the pharmacokinetic profile and assess bioequivalence between the test warfarin sodium tablet and reference product Coumadin (2.5 mg) in 56 healthy Chinese subjects under fasting and fed conditions. The plasma concentration of warfarin was analy zed by a validated liquid chromatography‐tandem mass spectrometry assay, and the reference‐scaled procedure was used to determine bioequivalence for the pharmacokinetics parameters. The results showed that the point estimate of geometric mean ratios of Cmax and AUC0 ‐t for warfarin were 103.21% and 99.31%, respectively, in the fasting condition and 100.62% and 98.98%, respectively, in the fed condition, and the 90% confidence intervals were all within the range of 90.00% ‐111.11%. The upper limit of the 90% confidence interval of estimated within‐subject variation ratios of the test and reference products was 1.33 for Cmax and 2.22 for AUC0 ‐t under the fasting condition and 1.68 for Cmax and 2.15 for AUC0 ‐t under the fed condition. Overall, bioequivalence of the 2 warfarin sodium products was demonstrated.
Authors: Rohanachandra YM, Amarabandu HGI, Rohanachandra LT Abstract Parenting with mental illness is associated with family conflicts, parenting difficulties, low parental confidence and increased mental health and behavioural problems in children. Family focused interventions improve child outcomes by about 40 %. However, such services are not available in Sri Lanka.A cross sectional descriptive study was carried out in the general adult psychiatry follow-up clinics in a Teaching Hospital in Colombo, Sri Lanka to assess the needs of parents with mental illness. A specifically designed interviewer administered que...
Authors: Charnsil C, Narkpongphun A, Chailangkarn K Abstract AIMS: This research examines the prevalence of post-traumatic stress disorder (PTSD) and its related factors in students whose school burned down, one month and six months after the incident. METHODS: A total of 56 students from grades one through six were invited to participate in this study with permission from their parents. Subjects were screened for PTSD by using UCLA PTSD Reaction Index (DSM-5 Version) during three periods: 1, 6, and 12 months after the incident. Children diagnosed with PTSD were interviewed by a child and adolescent psychiatris...
Consultations in Liver Disease
Vinod K. Rustgi
NORMAN GITLIN, MD, FRCP (LONDON), FRCPE (EDINBURGH), FAASLD, FACP, FACG
CLINICS IN LIVER DISEASE
Hippocrates (460-371 bc) first recognized the relationship between the neuropsychological and physiologic changes observed in liver disease (Figs. 1 and 2). At that time, Hippocrates noted that there was a poor clinical outcome associated with delirium that was preceded by jaundice.1
We present a brief overview of the potential prophylactic and treatment agents under investigation, some which could be initiated in the ED if proven effective.
[Daily Maverick] While the promise of repositioning 'old' drugs such as chloroquine and hydroxychloroquine is tantalising, it is critical that the hazards of using unapproved treatments are shared with the public to prevent needless fatalities and supply shortages that may further burden already strained healthcare systems.