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Sie suchen in allen Bereichen nach dem Autor Tillmanns S.
In der Rubrik Zeitschriften haben wir 1 Beitrag für Sie gefunden
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MerkenFrom Preclinics to Proof-of-Concept Clinical Trials
Rubrik: Fachthemen
(Treffer aus pharmind, Nr. 03, Seite 344 (2015))
From Preclinics to Proof-of-Concept Clinical Trials / A Development Pathway in Biotechnology · Tillmanns S · SuppreMol GmbH, Martinsried, Germany
For biotech companies, it is essential to generate first clinical efficacy data to attract investors. Preclinical efficacy models are needed to get a first idea on efficacy and target dose range and can already provide useful data on toxicity. Toxicological evaluations may include standard toxicological studies with the human investigational medicinal product (IMP) format, the development of an IMP surrogate, or humanised animal models. The determination of the no observed adverse effect level (NOAEL) or minimum anticipated biological effect level (MABEL) are important toxicological milestones prior to the start of first in human (FiH) clinical trials and proof-of-concept (PoC) studies. ...
