NTID

Special BE Considerations for Highly Variable and Narrow Therapeutic Index Drugs

Special BE Considerations for Highly Variable and Narrow Therapeutic Index Drugs

High Variability Drugs (HVDs) and Narrow Therapeutic Index Drugs (NTIDs) represent unique challenges in bioequivalence (BE) studies due to their specific pharmacokinetic characteristics. HVDs typically exhibit high intra-subject variability in drug absorption and distribution, meaning that the pharmacokinetic response can vary significantly within the same individual across different doses. Conversely, ... Read More