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…
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…
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…
A biowaiver allows a generic drug to be approved without an in vivo (BE) study based on in vitro dissolution data. This is particularly applicable BCS Class 1 drugs, which have high solubility and high permeability. Biowaiver Justification for BCS Class 1 Drugs To obtain a biowaiver for a BCS Class 1 drug, the following…
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