医薬品評価科学特論

新医薬品の研究開発・承認審査における評価科学の考え方と具体的な方法論を学ぶ。アカデミア、製薬企業、規制当局で新医薬品の研究開発・承認審査に携わる専門家により講義が行われる。講義では、非臨床（薬理・動態・毒性等）評価及び臨床評価（生物統計学等）、医薬品評価に関する規制・産業論・行政論の幅広いトピックが、具体的事例とともに解説される。

Students attending this course will learn about the concept of evaluation science and specific methodologies in the research, development and approval review of new medicines. Lectures are given by experts involved in the research, development and regulatory review of new drugs in academia, pharmaceutical companies and regulatory authorities. The lectures will cover a wide range of topics in non-clinical (eg, pharmacology, pharmacokinetics, toxicology, etc.) and clinical evaluation (eg, biostatistics, etc.), as well as regulatory, industrial and administrative theories related to drug evaluation, with specific examples.