课件：中美仿制药研发申报流程.pptVIP

QBR: Product Development Report for Complex Dosage Forms and NTI Drugs Drug Substance Which properties or physical chemical characteristics of the drug substance affect drug product performance? Excipients Is there any evidence of incompatibility between the excipients and drug substance? Formulation What is the formulation intended to do? What mechanism does it use to accomplish this? Were any other formulation alternatives investigated and how did these perform? Were any formulation optimization or sensitivity studies carried out for variations in composition around the final formulation? Were these studies sufficient to establish a design space for formulation composition? Is the formulation design consistent with the dosage form classification in the label? Drug Product What are the critical quality attributes that ensure the product will perform as labeled? QBR: Process Development Report Process Description Why was this manufacturing process selected for this drug product? Were alternative unit operations investigated by process development studies? Critical Steps and Scale Up How were the critical steps in the process identified? What are the critical process parameters for each critical step and how were they identified, monitored and/or controlled? Were process development studies that varied starting materials or operating parameters conducted? Were these studies sufficient to establish a design space for process? In process tests Why is each in process test required? How were the acceptance limits chosen? Why were the in-process tests identified as critical to product quality? What scale-up experience does the sponsor have with the unit operations in this process? QBR: Risk Summary NTI drug Classified as a non-NTI drug, risk score = + 0 Classified as an NTI drug, risk score = +1 Dosage Form Simple Dosage Form, risk score = + 0 Other Dosage Forms and NTI drugs, risk score = + 1 Development Report If the sponsor submits a development report that addre