Detection of out of trends (OOT) at release and in stability study. Determination of OOT limits from historical data, batch pooling evaluation, identification of worst batches (“worst” slopes) and tolerance interval of regression.
Hyphen-stat let healthcare companies, the pharmaceutical industry, biotech and related sectors such as cosmetics and agronomy to gain in quality and scientific knowledge through better exploitation of laboratory and production data.
Hyphen is a consulting company specializing in statistics and information technology founded by three Sanofi employees. The company is based on the Oncopôle biopark in Toulouse. The Hyphen team has many years of experience in the regulated fields and the development of software solutions for the pharmaceutical industry.