Translational strategies for development of antibody-based therapeutics should allow understanding of the relationship between the aunit dosea and aunit effecta with respect to both beneficial and deleterious effects from early stages of development. The flow of information from later to earlier stages of development should provide opportunities to facilitate selection of more effective novel and next-generation drug candidates. Selection and evaluation of relevant biomarkers in early preclinical development in qrelevantq animal models should allow for identifying potential risks to humans and establishing safe First-In-Human (FIH) dosing strategies. Hence, integration of knowledge with respect to target antigen properties such as antigen distribution, expression profile, kinetic properties, target pharmacology, antigen isoforms and pharmacological redundancy in health and disease, as well as antibody design criteria, such as antibody isotype, affinity, PK/PD and safety is a critical necessity for the design of effective translational strategies. Additionally, these factors will further offer critical differentiating characteristics for next-generation antibodies, and novel technologies prove instrumental in generation of biosuperior antibody candidates for market entry. This book will examine many important considerations necessary for the design of effective translational strategies during the development of antibody-based therapeutics.N Engl J Med 354(8):821a831 Milgrom H, Fick RB, Su JQ, Reimann JD, Bush RK , Watrous ML, Metzger WJ (1999) The ... Bekker PJ, Martin AW (2004) A PK/PD model developed in cynomolgus monkeys predicts concentrations and effects of AMG 162, a fully ... aapspharmaceutica.com/inside/focus_groups/ModelSim/ imagespdfs/04Peterson.pdf Putnam WS, Li J, Haggstrom J, Ng C, ... J Clin Pharmacol 45:468a476 Tabrizi MA, Roskos LK (2006) Exposurearesponse relationships foranbsp;...
|Title||:||Development of Antibody-Based Therapeutics|
|Author||:||Mohammad A. Tabrizi, Gadi G. Bornstein, Scott L. Klakamp|
|Publisher||:||Springer Science & Business Media - 2012-04-24|