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Three Regulatory Changes Rewiring How Medicines Are Developed

Three Regulatory Changes Rewiring How Medicines Are Developed

Mirjam Trame is the VP and head of pharmacometrics at Certara, specializing in model-informed drug development and regulatory science. getty​Most industries are transformed by new technologies. Drug development, however, is being reshaped by something much quieter: a change in what regulators consider credible scientific evidence. The biggest development this year was not a breakthrough therapy…