التفاصيل البيبلوغرافية
| العنوان: |
Surveys/Research Exploring Japanese Phase I Studies in Global Drug Development: Are They Necessary Prior to Joining Global Clinical Trials? |
| المؤلفون: |
Hirano, Masaru, Yamada, Masanori, Tanaka, Toshiaki, Koue, Toshiko, Saito, Tomohisa, Higashimori, Mitsuo, Ochiai, Hisao, Yamamoto, Junichi, Yaguchi, Saori, Mita, Sachiko, Hara, Katsutoshi |
| المصدر: |
Clinical Pharmacology in Drug Development; Dec2021, Vol. 10 Issue 12, p1410-1418, 9p |
| مصطلحات موضوعية: |
DRUG development, CLINICAL trials, ORGANIC anion transporters, IDIOPATHIC thrombocytopenic purpura, ANTINEOPLASTIC agents |
| مستخلص: |
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] |
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| قاعدة البيانات: |
Complementary Index |
