Early Phase Clinical Research

コースについて

Early phase clinical research is a bridge between early discovery and clinical research. As an exploratory study, early phase clinical research has a small sample size with limited data and some uncertainties. Its research content is changeable, characterized by diversification of high risk. The adoption of appropriate early-phase clinical research strategies and technologies provides an important guarantee for the success of drug research and development and can help companies manage their R&D expenses effectively.

This module focuses on early phase clinical research and explains the characteristics and knowledge of a drug’s early development based on clinical pharmacology. The workshop also covers important considerations in the design of early-phase clinical trials and offers guidance at the strategic level with regard to different indications (e.g., eye diseases, CNS disorders, oncological diseases) and different types of drugs (e.g., macromolecules and micromolecules) to help break through the bottleneck in innovative drug research and development.

ワークショップ Objective

  • Master the characteristics of the early development of specific drugs and essential clinical pharmacological knowledge
  • Acquire the key strategic considerations in early phase clinical research

ワークショップ Outline

  • From the perspective of clinical pharmacology, explain core knowledge involved in early phase drug development as well as the characteristics of developing specific drugs
  • Important considerations in early phase clinical research
    • Introduce the overview of early phase clinical research
    • Explain the important considerations during this process
    • Share the key points (e.g., the first-in-human clinical trial, drug-drug interaction test, TQT (c-QT) test, liver/kidney injury test) of a successful clinical pharmacological research through case studies
プログラム| Global Clinical Development Strategy Workshop Series

今日から始めましょう

私たちは、バイオ医薬品業界の専門家や幹部に対する高まる需要を満たすために、調整された、意味のある、効果的な教育およびトレーニングプログラムを開発します。当社のプログラムとカスタマイズされたトレーニングオプションの詳細を確認したり、無料の提案をリクエストしたりするには、お客様のニーズと希望する目標についてお問い合わせください。

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