Injectables

Biowaiver Eligibility for Injectable Formulations
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Biowaiver Eligibility for Injectable Formulations

ByPharma Lesson 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…

Extended Release Rates Technology for Injection Dosage Form

Extended Release Rates Technology for Injection Dosage Form

ByPharma Lesson Reading Time: 4 minutes

Extended-release injectable formulations are designed to release the active pharmaceutical ingredient (API) at a controlled rate over an extended period, from several hours to weeks. The primary goal of these formulations is to reduce the frequency of administration, minimize drug fluctuations, and maintain therapeutic drug levels, improving patient adherence and clinical efficacy. The development of…

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