BACKGROUND AND PURPOSE Genetic variation influences risk of intracerebral hemorrhage (ICH). Hypertension (HTN) is a potent risk factor for ICH and several common genetic variants (single nucleotide polymorphisms [SNPs]) associated with blood pressure levels have been identified. We sought to determine whether the cumulative burden of blood pressure-related SNPs is associated with risk of ICH an...

BACKGROUND Previous data suggest that systemic hypertension (HTN) is a risk factor for postcraniotomy intracranial hemorrhage (ICH). The authors examined the relation between perioperative blood pressure elevation and postoperative ICH using a retrospective case control design. METHODS The hospital's database of all patients undergoing craniotomy from 1976 to 1992 was screened. Coagulopathic ...

This study presents the characteristics that distinguish between idiopathic intracranial hypertension (ICH) and ICH caused by intracranial vascular damage. Twenty-one patients with ICH were included in this study. The analysis of the symptomatology correlated with the values of intracranial pressure, and the imaging findings revealed significant differences between these two types of ICH. ICH c...

BACKGROUND AND PURPOSE Limited data suggest that intracerebral hemorrhage related to oral anticoagulant therapy (OAT ICH) is associated with more hemorrhage expansion and a worse prognosis than spontaneous ICH (SICH). METHODS We examined patients enrolled in the placebo arm of the CHANT study, a prospective randomized trial of a putative neuroprotectant in patients with ICH. All patients had ...

In the present study, comprehensive stress testing of Dexketoprofen trometamol was carried out according to ICH guideline Q1A (R2). Dexketoprofen trometamol is subjected to stress conditions of hydrolysis, oxidation, photolysis and neutral decomposition. Additionally, the solid drug is subjected to 50 °C for 60 days in dry-bath, and to the combined effect of temperature and humidity, with and w...

Following the ICH E14 clinical evaluation guideline [1], the measurement of QT/QTc interval prolongation has become the standard surrogate biomarker for cardiac drug safety assessment and the faith of a drug development. In Thorough QT (TQT) study, a so-called positive control is employed to assess the ability of this study to detect the endpoint of interest, i.e. the QT prolongation by about f...

Gene therapy is a rapidly evolving field that needs an integrated approach, as acknowledged in the concept article on the revision of the guideline on gene transfer medicinal products. The first gene therapy application for marketing authorization was approved in the International Conference on Harmonisation (ICH) region in 2012, the product being Alipogene tiparvovec. The regulatory process fo...

Gene therapy is a rapidly evolving field, which needs an integrated approach, as acknowledged in the Concept paper on the revision of the guideline on gene transfer medicinal products (Concept paper, EMA, 2009). The first gene therapy application for marketing authorisation was approved in the ICH region in 2012, the product being Alipogene tiparvovec (http, summary for the public, 2012). The r...

Assessing the potential for a new drug to cause life-threatening arrhythmias is now an integral component of premarketing safety assessment. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline (ICH) E14 recommends the "Thorough QT Study" (TQT) to assess clinical QT risk. Such a study calls for careful evaluation of drug...

BACKGROUND AND PURPOSE Intracerebral hemorrhage (ICH) constitutes 10% to 15% of all strokes and remains without a treatment of proven benefit. Despite several existing outcome prediction models for ICH, there is no standard clinical grading scale for ICH analogous to those for traumatic brain injury, subarachnoid hemorrhage, or ischemic stroke. METHODS Records of all patients with acute ICH p...