Drug Evaluation Committee Clinical Pharmacological Evaluation of New Modality Development -Current Status, Issues, and Future Prospects-.
Clinical Evaluation Subcommittee
May 2024
There are a wide variety of modalities being developed for pharmaceutical products, and the number is expected to increase in the future. In the new modalities, clinical pharmacological evaluation of the effects of intrinsic and extrinsic factors on the risk/benefit balance of drugs (e.g., studies in patients with renal or hepatic dysfunction, drug interaction studies, thorough QT studies, evaluation of ethnic differences in pharmacokinetics, etc.), which have been conducted in conventional modalities such as small molecules, will be replaced in some cases with the evaluation of the effects of intrinsic factors on the risk/benefit balance of drugs. The role of clinical pharmacologists in pharmaceutical companies has reached a turning point, as it is often judged that evaluation is unnecessary except for the development of some nucleic acid drugs. Team 8 (Clinical Pharmacology) of the Clinical Evaluation Subcommittee defined nucleic acid drugs, gene therapy, and gene-cell therapy as novel modalities, and conducted a survey and discussion on the clinical pharmacological evaluation of these modalities. Based on the discussion, the team made recommendations on how clinical pharmacologists should be involved in the development of new modalities in the future. We hope that this report will serve as a compass for clinical pharmacologists who are developing new modalities.
Clinical Pharmacology Evaluation in the Development of New Modalities
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