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Biorelevant Media

Biorelevant Dissolution Media | FaSSIF & FeSSIF in Drug Development
ByPharma Lesson March 4, 2025 Reading Time: 2 minutes

In pharmaceutical development, FaSSIF and FeSSIF replicate intestinal conditions in fasting and fed states, aiding in predicting drug dissolution, absorption, and bioavailability. FaSSIF (Fasted State Simulated Intestinal Fluid) Purpose: Key Characteristics: Composition: Application: FeSSIF (Fed State Simulated Intestinal Fluid) Purpose: Key Characteristics: Composition: Application: Why Are These Media Important? Biorelevant Dissolution Testing: Food Effect Studies:…

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Bioequivalence

Bioequivalence Studies for Clear Oral Syrup
ByPharma Lesson March 4, 2025March 4, 2025 Reading Time: 2 minutes

BE studies for clear oral syrup solutions ensure that generic formulations provide the same therapeutic effect as the reference product. Unlike solid dosage forms, oral syrups are already in solution, which simplifies some BE requirements. However, factors such as excipients, solubility, and absorption characteristics can influence the need for in vivo studies. When Are BE…

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Analytical Development | Dissolution

Identifying Discriminatory Media and Its Role in Biopharmaceutical Studies
ByPharma Lesson March 4, 2025August 29, 2025 Reading Time: 2 minutes

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?…

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Bioequivalence

Pilot and Pivotal Bioequivalence (BE) Study Strategy for Generics
ByPharma Lesson March 4, 2025March 4, 2025 Reading Time: 2 minutes

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:…

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Bioequivalence

Regulatory Approaches for Bioequivalence Study of Highly Variable Drugs (HvD)
ByPharma Lesson February 28, 2025March 5, 2025 Reading Time: 2 minutes

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)…

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Biowaiver

Proportionality and Regulatory Considerations for Biowaivers in SR Dosage Forms
ByPharma Lesson February 28, 2025February 28, 2025 Reading Time: 2 minutes

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…

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