药事法施行细则第五条.pptVIP

IND-Preclinical Sciences Good IND Submission Chia-Hsin Yeh, Ph.D. Reviewer, Division of Preclinical Sciences Center for Drug Evaluation IND Evaluation in Preclinical Sciences Assure that the drug used in the proposed trial is efficacious and safe Satisfactory information is essential Based on scientific and regulatory considerations Major concern for quality and safety Regulatory Consideration 藥事法施行細則第五條 非販賣之研究、試製之藥品，應備有研究或試製紀錄，並以無商品化之包裝者為限 申請藥品臨床試驗計劃案應檢附資料 藥品特性資料(藥品物化性質、毒藥理作用、藥物動力學等非臨床及臨床試驗資料)或主持人手冊 製造管制標準書、批次製造紀錄、主成分及成品檢驗規格成績書及安定性試驗 (必要時得要求檢送其他資料) Relevant Regulatory Guidance DOH guidance --藥品非臨床試驗安全性規範 --藥品生體可用率及生體相等性試驗基準 --腎或肝功能不全病患的藥動學試驗基準 --藥品臨床試驗基準 ICH guidance: quality and safety issues Scientific Consideration Case by caseDepends on the development stage complexity of the case, preclinical requirements will be varied Consultation encouraged Save time and development effort Submission for Preclinical Sciences Requirement for: General information CMC information Pharm/Tox information Pharmacokinetic information CMC Requirements In general Sufficient information to assure identification, quality, purity, and strength of tested drug Information needed will vary with the phase, proposed duration, dosage form, and others Discuss with the Agency regarding type of manufacturing data that should be submitted to support the safe use of the drug CMC Requirements —Cont’ Phase 1 Adequate information for evaluation of the safety of subjects Able to relate the drug product in clinical study to the one in the animal toxicology studies CMC Requirements —Cont’ Phase 2 and 3 All updates or revisions of CMC information (e.g., manufacturing process, specifications, formulation) CMC Requirements —Cont’ For cases of new chemical entities (NCE) In general, the draft of IND process will be followed For cases of non-NCE A brief summary of chemical and physical properties of study medication Drug substance information Drug product information CMC Requir