Collection of Dose Adjustment and Therapeutic Monitoring Data to Aid Narrow Therapeutic Index Drug Classification (U01)

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Narrow therapeutic index (NTI) drugs are those drugs where small differences in dose or blood concentration may cause serious adverse events or therapeutic failure. In 2011, FDA proposed tighter quality and bioequivalence (BE) standards for NTI drugs. These new standards will further enhance the quality and therapeutic equivalence of generic NTI drugs. One challenge in implementing tighter quality and bioequivalence (BE) standards for NTI drugs is to identify drugs that can be classified as NTI drugs. It is believed that dose adjustment and therapeutic monitoring data in clinical practice can provide insight about the drug dose/concentration and response relationship which may help determine which drug falls into NTI category and may need tighter review criteria.The objective of this application is to collect drug dose adjustment and therapeutic monitoring data in patients to aid NTI classification. The outcome of this study can help FDA develop a NTI drug list and implement the NTI policy.

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