Lv2
140 积分 2023-07-24 加入
Review on requirements of drug allergy or pseudoallergic reactions in pre-clinical evaluation
16天前
已关闭
Should You Run a Dedicated TQT Study? Sponsor and Regulatory Considerations on Substitution Pathways to Assess QT Liability
22天前
已完结
The New S7B/E14 Q&A Document Provides Additional Opportunities to Replace the Thorough QT Study
22天前
已完结
Species selection for nonclinical safety assessment of drug candidates: Examples of current industry practice
27天前
已完结
Current practices on the measurement of electrocardiogram and hemodynamic parameters in non–rodent species in regulatory safety assessment studies
1个月前
已完结
A comprehensive review of 20 years of progress in nonclinical QT evaluation and proarrhythmic assessment
1个月前
已完结
Current practices on the measurement of electrocardiogram and hemodynamic parameters in non–rodent species in regulatory safety assessment studies
1个月前
已完结
Taking a deep breath: Evidence-based approaches to respiratory safety assessment
1个月前
已完结
Reevaluating Safety Pharmacology Respiratory studies within the ICH S7A Core Battery: A multi-company evaluation of preclinical utility and clinical translation
1个月前
已完结
Results from an EFPIA, JPMA, PhRMA industry survey on reopening and revamping the ICH S7A guidance on safety and secondary pharmacology
1个月前
已完结
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