GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline
نویسندگان
چکیده
منابع مشابه
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...
متن کاملBioanalytical method validation
A syntetic discussion on bioanalytical methods validation is presented from the point of view of regulatory documents, scientific articles and books. The validation parameters are described, together with an example of validation methodology applied in the case of chromatographic methods used in bioanalysis, taking in account to the recent Food and Drug Administration (FDA) guidelines and docum...
متن کاملStatistical principles for clinical trials (ICH E9): an introductory note on an international guideline.
The opportunity to write a truly international guideline on statistics is a rare one indeed. In 1995, the Steering Committee of the International Conference on Harmonisation1 (ICH) took a decision which was of major importance to all medical statisticians involved in the development of new medicinal products. This decision was to add a guideline on statistical methodology (E9) to the collection...
متن کامل24-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...
متن کاملRecovery from ICH – Potential Targets
Intracerebral hemorrhage (ICH) is a devastating clinical event caused by rupture of blood vessels and accumulation of blood in the brain. Many disorders, including hypertensive arteriosclerosis, amyloid angiopathy, neoplasia, coagulation disorders and cerebrovascular malformations, directly or indirectly damage blood vessels in the brain and thus lead to ICH. The annual occurrence of ICH is est...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Bioanalysis
سال: 2019
ISSN: 1757-6180,1757-6199
DOI: 10.4155/bio-2019-0207