Pharmaceutical Regulatory Affairs

Biography

Biography: Ting-Chao Chou

Abstract

Disparity in basic scientific concept and theory lead to weakness in setting policy and regulatory affairs. At least three major areas in biomedical-research and pharmaceutical development exist confusion that need clarifications to improve research efficiency, developmental cost-effectiveness and rigorous regulatory affairs: (I) Loose in consensus on “synergy definition and its quantification” in drug combination synergy claims, especially in cancer and AIDS. (II) The terms PK/PD referred as Pharmacokinetics and Pharmacodynamics are used casually, where PD dose-effect dynamics for effi cacy and toxicity algorithm for simulation is not yet defined clearly and with insufficient emphasis on PD comparing with PK. (III) The care and use of laboratory animals are good policy and regulation. However, the mass-action law-based conservation of animals to increase efficiency/cost-eff ectiveness and to minimize experimental size and data points, remain to be implemented and utilized. All the above important improvements can be implemented by employing the unified theory of the median-effect equation and the combination index theorem, based on the physico-chemical principle of mass-action law, using CompuSyn computer soft ware for automatic simulation, that have, so far, been adopted by >10,000 scientists in over 5,000 papers worldwide as indicated by Thomson Reuters Web of Science core database.