BE
Conducting BE Studies for NTI Drugs
Here’s a detailed explanation of how bioequivalence (BE) studies are conducted for narrow therapeutic index (NTI) drugs, including regulatory expectations, study design, analytical methods, and statistical analysis: Detailed Overview: Bioequivalence Study for NTI Drugs What are NTI Drugs? NTI (Narrow Therapeutic Index) drugs are those where small differences in dose ... Read More
Reference Standard (RS) in Bioequivalence Studies
Introduction In pharmaceutical development, a Reference Standard (RS), often referred to as a Reference Listed Drug (RLD) or comparator product, is a benchmark for evaluating the performance of generic drugs in bioequivalence (BE) studies. The RS ensures that generic drugs meet therapeutic equivalence standards, a critical step for regulatory approval. ... Read More
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