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. Confusion and controversy in at least three major areas in biomedical-research and pharmaceutical development exists that compromise research efficiency, developmental cost-effectiveness and rigorous regulatory policy and affairs, namely: (1) Lack of consensus on “synergy definition and its quantification” in drug combination and treatment, especially in cancer and AIDS. (2) The terms PK/PD referred as Pharmacokinetics and Pharmacodynamics are used casually where PD is poorly defined and neglected. (3) The “care and use” legislatures for laboratory animals are good policy and regulation. However, the basic means for conservation of laboratory animals “use”, for reducing waste and minimizing data points and experimental size is poorly developed. It is proposed that all the above three serious problems can be minimized by employing the unified theory of the ‘median-effect equation’ for single entity drugs, and the ‘combination index theorem’ of drug combinations, based on the physico-chemical principle of mass-action law. Its computer soft ware, “CompuSyn”, for automated simulation of pharmacodynamics for new drug evaluation and for synergy quantification, have already been adopted by >10,000 scientists worldwide and is growing at over 1,000 citation papers per year.