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.
Highlights
The importance of biopharmaceutical considerations in drug product development have been emphasized in the seminal work of Stanley Kaplan in the early 1970s [1,2]
The importance of biopharmaceutical considerations in pharmaceutical development has been incorporated in the relevant Quality-by-Design (QbD) and Biopharmaceutics Risk Assessment Roadmap (BioRAM) concepts
Long sought after as a surrogate for in vivo studies, in vitro dissolution testing is increasingly accepted as a reliable indicator of the drug product clinical performance when used complementary with physiologically based pharmacokinetic/biopharmaceutics modeling (PBPK/physiologically based biopharmaceutics models (PBBM)) and in vitro-in vivo correlation (IVIVC)
Summary
The importance of biopharmaceutical considerations in drug product development have been emphasized in the seminal work of Stanley Kaplan in the early 1970s [1,2]. The importance of biopharmaceutical considerations in pharmaceutical development has been incorporated in the relevant Quality-by-Design (QbD) and Biopharmaceutics Risk Assessment Roadmap (BioRAM) concepts. These contemporary approaches which put the patient at the centre of the drug product development by exploring the specific patient needs, expectations and the desired therapeutic outcome, aim to link drug product physicochemical and biological properties (i.e. Critical Quality Attributes, CQA) with its clinical performance [5,6,7,8,9]. Different biopharmaceutical tools and principles governing application of the integrated biopharmaceutical approach in pharmaceutical development and drug characterization are reviewed
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