Bridging studies for NTI generics ensure that life-critical generic drugs like warfarin and levothyroxine are as safe and effective as brand-name versions. Stricter bioequivalence standards, complex study designs, and higher costs make these approvals rare-but essential for patient safety.
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Partial AUC is a precise pharmacokinetic tool used to evaluate bioequivalence in complex drug formulations where traditional metrics fall short. It measures drug exposure during clinically relevant time windows, ensuring safer and more effective generic medicines.
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Bioequivalence studies must now account for age and sex differences to ensure generic drugs work safely for everyone. Learn how regulators are changing rules and why older adults and women are finally being included.
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