From Target Selection to the Minimum Acceptable Biological Effect Level for Human Study: Use of Mechanism-based PK/PD Modeling to Design Safe and Efficacious Biologics

Journal Title: The AAPS Journal - Year 2011, Vol 13, Issue 2

Abstract

The online version of this article (doi:10.1208/s12248-011-9256-y) contains supplementary material, which is available to authorized users.

Authors and Affiliations

Jing Yu, Helene Karcher, Adam L. Feire, Philip J. Lowe

Keywords

Related Articles

Pharmacokinetic and Pharmacodynamic Modeling of a Monoclonal Antibody Antagonist of Glucagon Receptor in Male ob/ob Mice

Elevated basal concentrations of glucagon and reduced postprandial glucagon suppression are partly responsible for the increased hepatic glucose production seen in type 2 diabetic patients. Recently, it was demonstrated...

No evidence for the involvement of the multidrug resistance-associated protein and/or the monocarboxylic acid transporter in the intestinal transport of fluvastatin in rats

Fluvastatin, an amphiphilic anion, shows a nonlinear increase in effective intestinal permeability (Peff) with increasing lumenal concentrations in rats. The main objective of this study was to investigate whether or not...

Use of a Local Sensitivity Analysis to Inform Study Design Based on a Mechanistic Toxicokinetic Model for γ-Hydroxybutyric Acid

γ-Hydroxybutyric acid (GHB), a drug of abuse, demonstrates complex toxicokinetics with capacity-limited metabolism and active renal reabsorption. The objectives of the present study were to conduct a local sensit...

Design and synthesis of the CB1 selective cannabinoid antagonist AM281: A potential human SPECT ligand

In the search for a radioligand capable of imaging cannabinoid CB1 receptors in the living human brain by SPECT (single photon emission computed tomography), N-(morpholin-4-yl)-1-(2,4-dichlorophenyl)-5-(4-iodophenyl)-4-m...

Download PDF file
  • EP ID EP681301
  • DOI  10.1208/s12248-011-9256-y
  • Views 109
  • Downloads 0

How To Cite

Jing Yu, Helene Karcher, Adam L. Feire, Philip J. Lowe (2011). From Target Selection to the Minimum Acceptable Biological Effect Level for Human Study: Use of Mechanism-based PK/PD Modeling to Design Safe and Efficacious Biologics. The AAPS Journal, 13(2), -. https://europub.co.uk/articles/-A-681301