Use of the Weight of Evidence approach as an alternative to nonhuman primate developmental and reproductive toxicity testing for biopharmaceuticals — PMDA Early Consideration Summary
Thoughts on the Use of Weight of Evidence Approach in Nonclinical Safety Evaluation — PMDA Early Consideration Summary
Points to consider for the discussion with PMDA using the ICH S1B (R1) guideline and in the approval application — PMDA Early Consideration Summary
Points to Consider for Replacement of Conventional Tests for Viruses with Next Generation Sequencing (NGS) Assays — PMDA Early Consideration Summary
Considerations on Utilization of the Platform-based Approach in Non-Clinical Safety Evaluation of mRNA-LNP Vaccines for Prevention of Infections — PMDA Early Consideration Summary
Considerations for the General Toxicity Evaluation of Monoclonal Antibodies — PMDA Early Consideration Summary
Considerations for Non-Clinical Studies in the Development of Diagnostic Radiopharmaceuticals — PMDA Early Consideration Summary
Considerations for Non-clinical Studies of Combination Prescription Drugs with Similar Formulations — PMDA Early Consideration Summary
Concept of New Approach Methodologies (NAMs) use in quasi-drug applications — PMDA Early Consideration Summary