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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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Biowaiver

Biowaiver Considerations for Sustained-Release (SR) Dosage Forms
ByPharma Lesson February 22, 2025February 22, 2025 Reading Time: 2 minutes

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…

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Biowaiver | Injectables

Biowaiver Eligibility for Injectable Formulations
ByPharma Lesson February 22, 2025February 22, 2025 Reading Time: 2 minutes

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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Biowaiver

Biowaiver for Topical Dosage Forms
ByPharma Lesson February 22, 2025February 22, 2025 Reading Time: 2 minutes

A Biowaiver for a topical dosage form refers to regulatory approval for marketing a generic topical product without conducting in vivo bioequivalence (BE) studies. Instead, equivalence is demonstrated using in vitro methods and other scientific justifications. Key Considerations for Biowaiver of Topical Dosage Forms Regulatory agencies such as USFDA, EMA, and WHO provide guidelines for…

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Biowaiver

Biowaiver Criteria for Multiple Strengths Across Regulatory Bodies
ByPharma Lesson February 21, 2025February 21, 2025 Reading Time: 2 minutes

When BE is demonstrated for one strength of a drug product, regulatory agencies allow a biowaiver for additional strengths under certain conditions. The key criteria vary across USFDA, EMA, WHO, MHRA, TGA, and CDSCO but are largely aligned on fundamental principles. USFDA Biowaiver Criteria Biowaiver is allowed for additional strengths if: EMA Biowaiver Criteria Follows…

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