A Review on Revision of ICH Q2 (R1) and New ICH Q14 Guidance

ICH guidelines: inception, revision, and implications for drug development.

Since the inception of the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) in 1990, six-party Expert Working Groups (EWG) have developed and revised numerous guidelines on preclinical safety evaluation (Table 1). The six parties to ICH represent the regulatory bodies and pharmaceutical manufacturing organizations in...

24-Hour ICH Score Is a Better Predictor of Outcome than Admission ICH Score

BACKGROUND The ICH score is a validated tool for predicting 30-day morbidity and mortality in patients with intracerebral hemorrhage. AIMS AND/OR HYPOTHESIS The aim of this study is to determine if the ICH score calculated 24 hours after admission is a better predictor of mortality than the ICH score calculated on admission. METHODS Patients presenting to our center with ICH from 7/08-12/10...

Ich (White Spot Disease)

Fish infected with Ich may have white specks on their skin as though they were sprinkled with salt (Fig. 1). Because of this appearance, Ich is sometimes called white spot disease. The skin of the fish may also look bumpy. Mature forms of the parasite are large (up to 1 mm or 1/32 inch across) and can be seen without magnification. Ich often causes the fish to have large amounts of mucus slough...

ICH guideline S2 (R1) - Genotoxicity testing and data interpretation for pharmaceuticals intended for human use

ADR: a new global phenomenon, thanks to the ICH.