Affiliation:
1. Faculty of Pharmacy, Department of Pharmaceutical Technology and Cosmetology, University of Belgrade, Belgrade, Serbia
Abstract
The importance of biopharmaceutical considerations in pharmaceutical
development and drug characterization has been well recognized both by
pharmaceutical industry and regulatory authorities as a tool to establish
predictive relationships between drug product quality attributes (in vitro
data) and its clinical performance (in vivo data). In the present paper,
contemporary biopharmaceutics toolkit including in vivo predictive
dissolution testing, Biopharmaceutics Classification System, physiologically
based pharmacokinetic and biopharmaceutics modeling and simulation, in
vitro-in vivo correlation and biowaiver, are reviewed with regards to
relevant general principles and applicability. The recently introduced
innovative strategy for patient-centric drug development using an integrated
systems approach grounded in fundamental biopharmaceutics concepts, clinical
insights and therapeutic drug delivery targets, described as
Biopharmaceutics Risk Assessment Roadmap (BioRAM) is also presented. Further
development in the field will benefit from joint efforts and exchange of
knowledge and experiences between pharmaceutical industry and regulatory
authorities for the common goal to accelerate development of effective and
safe drug products designed in accordance with patients? needs and
expectations.
Publisher
National Library of Serbia
Subject
General Chemical Engineering,General Chemistry
Cited by
1 articles.
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