Sentence examples for data in the dossier from inspiring English sources

Clinical data in the dossier were based on a MenA conjugate vaccine that used group A polysaccharide made at SynCo Bio Partners in Amsterdam.

A stable drug substance was filed with 6 month ICH/registration data in the initial registration dossier.

In six of the 12 cases where the comparator used in the phase III trials differed from the ACT recommended by G-BA, the manufacturer included an indirect comparison of data from two separate trials in the dossier.

This template contains detailed requirements on the information to be included in the dossier.

All available information on adverse events has to be included in the dossier [ 3, 4].

The requirement for "general recognition" of safety is often satisfied through publication of the pivotal safety data in the peer-reviewed literature, and cited in the GRAS dossier or notification submission.

"He broke a lamp," Hirsch wrote in the dossier.

" 'Don't worry so much, Dad,' " Hirsch wrote in the dossier.

"It was included in the dossier against our wishes.

Campbell remained intimately involved in the dossier's progress.

Some methodological specifications are provided in the dossier template (Section 4.2.5.6 Suppl. G-BA VerfO).