Translation of Monoclonal Antibodies Pharmacokinetics from Animal to Human Using Physiologically Based Modeling in Open Systems Pharmacology (OSP) Suite: A Retrospective Analysis of Bevacizumab.

Interspecies translation of monoclonal antibodies (mAbs) pharmacokinetics (PK) in presence of target-mediated drug disposition (TMDD) is particularly challenging. Incorporation of TMDD in physiologically based PK (PBPK) modeling is recent and needs to be consolidated and generalized to provide better prediction of TMDD regarding inter-species translation during preclinical and clinical development steps of mAbs. The objective of this study was to develop a generic PBPK translational approach for mAbs using the open-source software (PK-Sim and Mobi).

Review of the Existing Translational Pharmacokinetics Modeling Approaches Specific to Monoclonal Antibodies (mAbs) to Support the First-In-Human (FIH) Dose Selection.

The interest in therapeutic monoclonal antibodies (mAbs) has continuously growing in several diseases. However, their pharmacokinetics (PK) is complex due to their target-mediated drug disposition (TMDD) profiles which can induce a non-linear PK. This point is particularly challenging during the pre-clinical and translational development of a new mAb.

Impact of platelet inhibition level on subsequent no-reflow in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.

Background: High P2Y platelet reactivity (PR) level after primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI) affects prognosis and may induce the no-reflow phenomenon.

Aim: To investigate the role of PR in the genesis of microvascular obstruction.

Methods: Patients with STEMI undergoing PPCI within 12hours of symptoms onset were included prospectively.

Feasibility study of a cosmetic cream added with aqueous extract and oil from date (Phoenix dactylifera L.) fruit seed using experimental design.

This article reports on the feasibility study of a cosmetic cream added with aqueous extract and oil from date (Phoenix dactylifera L.) fruit seed using experimental design. First, the mixture design was applied to optimize the cosmetic formula.

Feasibility study of date (Phoenix dactylifera L.) fruit syrup-based natural jelly using central composite design.

A feasibility study of natural fruit jelly from three Algerian raw materials, namely date (Phoenix dactylifera l.) fruit syrup and suspension of orange albedo powder (OAP) in lemon juice (LJ) was performed by response surface methodology (RSM) based on central composite design (CCD). The textural properties of the final jelly were investigated through two dependent variables: hardness and stickiness.