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Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
This guidance focuses on expedited safety reporting requirements for human drug and biological products that are being investigated under an IND and for drugs that are the subjects of bioavailability (BA) and bioequivalence (BE) studies that are exempt from the IND requirements. FDA: Adverse Event Reporting to IRBs. [26]
The STROBE Statement has also been adapted as a public, open-source repository for epidemiological research methods and reporting skills for observational studies. Epidemiologists, statisticians, and public health researchers are able to comment and edit the tool to inform future updates of the reporting guideline. [27]
Relative bioavailability is one of the measures used to assess bioequivalence (BE) between two drug products. For FDA approval, a generic manufacturer must demonstrate that the 90% confidence interval for the ratio of the mean responses (usually of AUC and the maximum concentration, C max ) of its product to that of the "brand name drug" [OB ...
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
An investigation of unmarked graves recently solved the mystery – and the city has honored him in a memorial. A Tulsa Race Massacre victim was recently ID’d as a World War I veteran. The city ...
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By Krystal Hu and Kenrick Cai (Reuters) -Elon Musk's SpaceX is preparing to launch a tender offer in December to sell existing shares at a price of $135 per share, two sources familiar with the ...