What is a Discriminatory Medium? A discriminatory medium in biopharmaceutical studies is a dissolution medium that can effectively differentiate between formulations based on their in vitro drug release characteristics. It is designed to highlight differences in formulation, process variables, or drug substance properties that may impact in vivo performance. Why is a Discriminatory Medium Important?…
Pilot BE Study with Two Dosing Strategies To optimize the formulation before the pivotal BE study, two pilot BE studies are conducted with different dissolution behaviors: Strategy 1: Formulation with Matching Dissolution in Discriminating Media Strategy 2: Formulation with Faster or Slower Dissolution (Depending on Dosage Form) Pilot BE Study Strategy Study Design Dosing Strategies:…
HvD pose a unique challenge in generic drug development due to their high intra-subject variability (CV > 30%) in pharmacokinetics. This variability complicates BE studies, requiring different regulatory agencies to adopt distinct approaches to ensure therapeutic equivalence without clinical hurdles. Key Regulatory Approaches for HvD Generic Drug Approval USFDA Approach – Reference-Scaled Average Bioequivalence (RSABE)…
For SR formulations, the rate-controlling polymer plays a crucial role in drug release. When seeking a biowaiver for a lower strength, regulatory agencies assess whether the polymer content is proportional or if adjustments impact drug release. Proportionality of Rate-Controlling Polymer Across Strengths Lower strengths may qualify for a biowaiver if the polymer-to-drug ratio remains the…
A biowaiver for a sustained-release (SR) dosage form is generally more challenging to obtain compared to immediate-release (IR) forms due to the complexity of drug release mechanisms and potential impact on bioavailability. However, under certain conditions, a biowaiver may be possible based on in vitro dissolution studies and in vivo-in vitro correlation (IVIVC). Key Considerations…
For injectable formulations, biowaiver eligibility depends on several factors, including the type of injectable (solution, suspension, emulsion), formulation differences, and regulatory guidelines from agencies like the USFDA, EMA, and WHO. Here are the general biowaiver requirements for injectable projects: Biowaiver for Parenteral (Injectable) Solutions For biowaivers to be granted for injectables, the formulation must meet…
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