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(2014)TOPRA, 11th Annual symposium, Abstracts. Mark abstract Several guidelines (e.g. ICH) define starting materials for a medicinal drug substance. While a consensus approach for defining the starting material in the synthesis of small molecule API is currently more or less being agreed upon due to the straightforward production process and well characterized API structure, this is not so as the drug nature complicates, e.g. biopharma and Advanced Therapy Medicinal Products (ATMPs). Although some general guidelines are present, Regulatory Authorities and pharmaceutical manufacturers should establish clear approaches for starting material definitions for these complicated APIs, as this will speed up the development and approval process for the benefit of the patient.

Please use this url to cite or link to this publication: http://hdl.handle.net/1854/LU-5735607



Autor: Matthias D-Hondt, Nathalie Bracke and Bart De Spiegeleer

Fuente: https://biblio.ugent.be/publication/5735607



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