Clinical Pharmacology Strategy for Registration in Japan with a Case Example of Posaconazole, a Globally Approved Triazole Antifungal Drug with Broad-spectrum Antifungal Activity
Author:
Affiliation:
1. Clinical Pharmacology Development, MSD K.K., Tokyo, Japan
2. MRL, Merck & Co., Inc., Rahway, NJ, USA
Publisher
Japanese Society of Clinical Pharmacology and Therapeutics
Link
https://www.jstage.jst.go.jp/article/jscpt/55/3/55_99/_pdf
Reference63 articles.
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3. 3) Masters JC, Cook JA, Anderson G, Nucci G, Colzi A, Hellio MP, et al. Ensuring diversity in clinical trials: the role of clinical pharmacology. Contemp Clin Trials. 2022; 118: 106807. doi: 10.1016/j.cct.2022.106807.
4. 4) Takahashi Y. Trend of modality on new drug discovery. Seisakuken-News. 2021; 64: 44-52. [https://www.jpma.or.jp/opir/news/064/64_6.pdf (accessed 2023-11-06)](in Japanese)
5. 5) EFPIA MID3 Workgroup; Marshall SF, Burghaus R, Cosson V, Cheung SYA, Chenel M, DellaPasqua O, et al. Good practices in model-informed drug discovery and development: practice, application, and documentation. CPT Pharmacometrics Syst Pharmacol. 2016; 5(3): 93-122. doi: 10.1002/psp4.12049.
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