A Journal of Postdoctoral Research.
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Preclinical development of the antimicrobial peptide M33 and onset of regulatory procedur
Pini A
Università di Siena
Dip. di Biotecnologie Mediche, Università di Siena, Italy.

Background. This is a project aimed at the pharmaceutical development of a new antimicrobial peptide (M33) discovered at the University of Siena. M33 showed a strong activity in vitro and in vivo against a panel of bacteria generally involved in CF infections.

Hypothesis and objectives. Before arriving to human experimentation, a new drug must be developed preclinically and this includes the study of pharmacokinetic, bio-distribution and toxicity profiles in animals. This project was exactly designed for the evaluations of these issues. At the end of preclinical procedures of development, regulatory documents for the request of a Clinical Trial Authorization will be submitted to competent authorities.


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