The periodic safety reporting to regulatory authorities is globally harmonized for postmarketing medicinal products by the International Conference on Harmonisation (ICH) guidelines, and is being extended for investigational drugs. To facilitate effective safety risk communication regarding investigational drugs, and to reduce duplicate periodic reporting to the US and EU by sponsors during dev...

background: intracerebral hemorrhage (ich) is a stroke type which resulted in disability. memantine have been supposed to have the effect on the functional status in patients with ich. objectives: comparing the effect of memantine with placebo on the clinical outcome of ich. materials and methods: this double-blind clinical trial was conducted in an academic hospital in northern iran on patien...

Intracerebral hemorrhage (ICH) accounts for 10 to 20% of all strokes. It is the leading cause of all strokes, second only to cerebral infarction [1]. Hypertension is the single most important risk factor for ICH, often leading to solitary ICH [2,3]. Though hypertension can lead to recurrent ICH, the occurrence of multiple simultaneous ICH is rare [4]. The occurrence of multiple simultaneous ICH...

BACKGROUND AND PURPOSE Intracerebral hemorrhage (ICH), the acute manifestation of a common progressive cerebrovascular disease of the elderly, is the most fatal and least treatable form of stroke. There is a desperate need for ICH-specific therapeutics and effective primary prevention strategies, a need that is certain to grow with the aging of the population. Data point to a sizable genetic co...

In diesem Jahr möchte ich nach längerer Pause wieder in den Skiurlaub fahren. Leider sind mir meine alten Skier zu klein, und so stehe ich vor der Frage, ob ich mir Skier leihen oder doch lieber kaufen soll. Wenn ich sie mir leihe, so muss ich pro Tag 10 Euro Leihgebühr zahlen. Für die 7 Tage meines Urlaubs würde ich also 70 Euro zahlen. Wenn ich mir Skier kaufe, so fallen Kosten von 140 Euro a...

Objective: Intracerebral hemorrhage (ICH) following systemic and chronic hypertension is one of the main causes of acute stroke leading to disability and death. Identifying the risk factors in ICH patients can be effective in reducing bleeding and the rates of mortality and disability in these patients. This study was carried out to investigate the factors associated with ICH.Methods: A t...

BACKGROUND AND PURPOSE The purpose of this study was to further analyze the temporal patterns of onset of intracerebral hemorrhage (ICH) and to determine whether or not subgroups with specific clinical characteristics exhibit different patterns of onset. METHODS The daily, weekly, and yearly variations in occurrence of ICH together with the relationship between ICH occurrence and changes in a...

Biosimilar approval guidelines need rationalization and harmonization to remove the inconsistencies misconceptions enable faster, safer, more cost-effective biosimilars. This paper proposes a platform for model guideline based on scientific evaluation of regulatory filings 130+ products approved in US, UK, EU hundreds WHO member countries. Extensive literature survey clinical data published rep...

BACKGROUND AND PURPOSE The aim of this study was to estimate the annual adult incidence and risk of intracerebral hemorrhage (ICH) and oral anticoagulant-associated ICH (OAC-ICH) in the Netherlands. METHODS We retrospectively selected all consecutive adult patients with a nontraumatic ICH seen in 1 of 3 hospitals in the region South-Limburg, the Netherlands, from 2007 to 2009. Crude incidence...