Challenges in the transition to model-based development
Journal Title: The AAPS Journal - Year 2005, Vol 7, Issue 2
Abstract
Authors and Affiliations
Thaddeus H. Grasela, Jill Fiedler-Kelly, Cynthia A. Walawander, Joel S. Owen, Brenda B. Cirincione, Kathleen E. Reitz, Elizabeth A. Ludwig, Julie A. Passarell, Charles W. Dement
High-Throughput Biophysical Analysis of Protein Therapeutics to Examine Interrelationships Between Aggregate Formation and Conformational Stability
Stabilization and formulation of therapeutic proteins against physical instability, both structural alterations and aggregation, is particularly challenging not only due to each protein’s unique physicochemical c...
Erratum to: Pharmacokinetic and Pharmacodynamic Analysis of Hyperthermic Intraperitoneal Oxaliplatin-Induced Neutropenia in Subjects with Peritoneal Carcinomatosis
The online version of the original article can be found at http://dx.doi.org/10.1208/s12248-010-9249-2.
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A Semi-mechanistic Model for the Effects of a Novel Glucagon Receptor Antagonist on Glucagon and the Interaction Between Glucose, Glucagon, and Insulin Applied to Adaptive Phase II Design
A potent novel compound (MK-3577) was developed for the treatment of type 2 diabetes mellitus (T2DM) through blocking the glucagon receptor. A semi-mechanistic model was developed to describe the drug effect on glucagon...
Development of a Complex Parent-Metabolite Joint Population Pharmacokinetic Model
This study aimed to develop a joint population pharmacokinetic model for an antipsychotic agent in development ({"type":"entrez-protein","attrs":{"text":"S33138","term_id":"423514","term_text":"pir||S33138"}} S33138) and...