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Quality expectations and tolerance limits of trial master files (TMF) – Developing a risk-based approach for quality assessments of TMFs by Hecht, Arthur, Busch-Heidger, Barbara, Gertzen, Heiner, Pfister, Heike, Ruhfus, Birgit, Sanden, Per-Holger, Schmidt, Gabriele B.
Published 2015-12-01
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