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The favourable outcomes of the patients receiving cells for PTLD and the high proportion of patients dying pre-licensure support the view that CTLs comprise an effective treatment modality.
It is a common practice to place the toxicology and the first GMP lot on stability studies, to collect the stability data throughout the clinical development to support licensure.
The present study was conducted to generate data to support licensure of combined DTP-HB-Hib vaccine in Indonesia.
In Canada, changes to the Immigration Act Regulation favour the immigration of physicians and increased efforts are being made to support licensure of foreign-trained physicians.
We report results of three Phase I studies undertaken to support licensure of the liquid formulation of the human RV vaccine in China.
The challenge for the US FDA and other national regulatory authorities is to ensure safe and effective vaccines in a timely fashion through the evaluation of clinical data to support licensure [ 23].
As part of the regulatory evaluation of this vaccine to support licensure in China, we report data from 2 clinical trials conducted in teenage/adolescent girls and adult women.
We report the findings of three randomized, double-blind, placebo-controlled Phase I studies undertaken to support licensure of the liquid formulation of the human G1P[8] rotavirus (RV) vaccine (RIX4414; GlaxoSmithKline Biologicals SA) in China.
The immunogenicity and safety of PCV13 has been demonstrated in a clinical programme that supported licensure.
- The design of the clinical studies that supported licensure of MeNZB relied on knowledge gained through the development of the two other extensively tested wtOMV vaccines from Cuba and Norway.
We did not consider the pivotal clinical immunogenicity trials that supported licensure of PCV13 for adults ≥50 y of age because the results were not available to us when we wrote our paper.
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