Advanced therapies are changing the treatment landscape for genetic disorders, cancers and conditions with limited treatment options. However,...
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Drug development increasingly depends on quantitative evidence to guide decisions on dosing, efficacy, safety and clinical trial design. The c...
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Drug development is entering a new phase of nonclinical testing. New Approach Methodologies (NAMs) are creating opportunities to generate more...
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Real-world evidence (RWE) is becoming an increasingly important part of evidence generation in medicines regulation. In Europe, the Data Analy...
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Artificial intelligence is moving quickly from experimentation into practical use across the pharmaceutical industry. Regulatory teams are alr...
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Japan is taking an important step toward integrating pediatric drug development more closely into global pharmaceutical development programs....
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