Allan King

専門情報

専門

Medical Japanese (clinical studies, protocols, clinical study reports, Investigator's Brochures, PMDA exchanges, regulatory documentation, PSURs, preclinical studies, etc.) Translation expertise (専門分野): • Clinical trials (臨床試験) Protocols (治験実施計画書), Clinical Study Reports (CSR) (治験総括報告書), interim reports (中間報告書), Case Report Forms (CRS) (症例報告書), Investigator Brochures (IB) (治験薬概要書), informed consent forms (同意文書) • Nonclinical studies (非臨床試験) Toxicology (毒性試験, 単回投与毒性試験, 反復投与毒性試験, 遺伝毒性試験, がん原性試験, 催寄形性試験, 生殖発生毒性試験), pharmacology (薬理試験, 安全性薬理試験), pharmacokinetics and pharmacodynamics (薬物動態と薬力学) • Pharmaceutical/medical device regulatory documentation and applications for marketing approval (医薬品・医療機器に関連する規制当局の文書, 製造販売承認申請書) PMDA consultations (独立行政法人医薬品医療機器総合機構との相談), PMDA queries (照会事項), PMDA review reports (審査報告書), Periodic Safety Reports (国内安全性定期報告), Periodic Safety Update Reports (PSUR) (定期的安全性最新報告), post-marketing surveillance (市販後調査査, 使用成績調査)

バックグラウンド

Professional translator since 1991. Initially worked as an in-house patent translator (chemistry, biochemistry, medical devices, pharmaceuticals), then progressed to free-lance work in 2000, specializing in clinical pharmaceutical development and regulatory translations.