BACKGROUND Intraventricular hemorrhage (IVH) extension is common following acute intracerebral hemorrhage (ICH) and is associated with poor prognosis. AIM To determine whether intensive blood pressure (BP)-lowering therapy reduces IVH growth. METHODS Pooled analyses of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trials (INTERACT1 and INTERACT2) computed tomography (C...

BACKGROUND Rates of acute intracerebral hemorrhage (ICH) increase in winter months but the magnitude of risk is unknown. We aimed to quantify the association of ambient temperature with the risk of ICH in the Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT2) participants on an hourly timescale. METHODS INTERACT2 was an international, open, blinded endpoint, ra...

A simple, rapid, accurate, precise, and economic Spectrophotometric method for formulated microspheres dosage form has been developed. Capecitabine shows absorbance maximum at different wavelength in different solvents, so absorbance was measured and the same wavelengths used for the estimation of Capecitabine in respective solvents. Capecitabine obey the beer lamberts’ law. Method is validated...

BACKGROUND The ICH E7 guideline intends to improve the knowledge about medicines in geriatric patients. As a legislative document, it might not reflect the needs of healthcare professionals. This study investigated what information healthcare professionals, regulatory agencies and pharmaceutical industries consider necessary for rational drug prescribing to older individuals. METHODS AND FIND...

obtaining a marketing authorization of an investigational medicinal product in the European Union, Japan, or the United States. One of the most critical of the documents submitted as part of the Common Technical Document, masterpiece of a marketing authorization application, is the Clinical Study Report, which represents the integrated full report of efficacy and safety data for an individual s...

OBJECTIVE This study tested the hypothesis that patients without placement of new do-not-resuscitate (DNR) orders during the first 5 days after intracerebral hemorrhage (ICH) have lower 30-day mortality than predicted by the ICH Score without an increase in severe disability at 90 days. METHODS This was a prospective, multicenter, observational cohort study at 4 academic medical centers and o...

Regulatory and industrial scientists collaborated to publish a "points to consider" document regarding the safety assessment of biotechnology-derived pharmaceuticals in non-clinical studies in 2002 (Pharmaceutical Non-clinical Investigation Group, 2002). The collaboration team intended to clarify the interpretation of ICH-S6 guideline and furthermore share recent Japanese practices on this matt...