Abstract
The Assessment of The Quality, Efficacy and Safety of The Investigational Medicinal Product in The Absence of An Approved Registration Dossier
Highlights
Today the pharmaceutical industry is one of the highly regulated fields with many rules and regulations which are quite volatile and are updated at least every decade [1-8]
The procedure for the production and release of each batch of medicinal product is typically based on requirements of Good Manufacturing Practice (GMP)
They are adequate for the developed and registered drug but difficult to follow for investigational medicinal product intended for clinical trials
Summary
Today the pharmaceutical industry is one of the highly regulated fields with many rules and regulations which are quite volatile and are updated at least every decade [1-8]. The Assessment of The Quality, Efficacy and Safety of The Investigational Medicinal Submission: July 30, 2019; Published: August 14, 2019 *Corresponding author: Voronina Ekaterina Vladimirovna, Researcher, Federal Institution “State Research Institute of Genetics and Selection of Industrial Microorganisms of the National Research Center” Kurchatov Institute”, Moscow, Russia Head of eukaryotic cultivation unit, LLC Pharmapark, Moscow, Russia
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