Surveys/Research Exploring Japanese Phase I Studies in Global Drug Development: Are They Necessary Prior to Joining Global Clinical Trials?

In this survey, 4 such cases were identified; for 3 drugs (oral to intravenous, oral to intramuscular, and oral to ocular injection) J-PhI study waivers were accepted, but for 1 drug (subcutaneous to intravenous) the waiver was not accepted. For small-molecule drugs, 5 drugs were successfully waived (dosing route: inhalation, ocular instillation, intramuscular, intravenous or subcutaneous injection) due to at least 1 reason in Table 1. Keywords: ethnic sensitivity/difference; dosage regimen; drug dose; Japanese; phase I study; regulatory science EN ethnic sensitivity/difference dosage regimen drug dose Japanese phase I study regulatory science 1410 1418 9 12/13/21 20211201 NES 211201 The pharmacokinetic (PK) and the pharmacodynamic (PD) properties of a drug and correlations of PK and PD with clinical efficacy and safety are important to assess the sensitivity of a drug to potential differences between ethnic groups. [Extracted from the article]