Biowaivers and Regulatory Exemptions
Biowaivers are regulatory exemptions granted for certain bioequivalence studies, allowing for the approval of generic drugs without conducting comparative clinical trials. These waivers are based on the demonstration of similarity in drug absorption between the generic and reference products using in vitro dissolution testing or other surrogate measures. Biowaivers streamline the drug approval process, saving time and resources while maintaining confidence in the equivalence of generic medications, particularly for well-understood drugs with predictable pharmacokinetics.
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Biowaivers and Regulatory Exemptions Conference Speakers
Recommended Sessions
- Analytical Techniques in Bioequivalence Assessment
- Bioavailability Enhancement Strategies
- Bioequivalence of Generic Drugs and Biosimilars
- Bioequivalence of Narrow Therapeutic Index Drugs
- Bioequivalence Study Designs and Methodologies
- Biosimilars
- Biowaivers
- Biowaivers and Regulatory Exemptions
- Drug Transporters and Bioequivalence
- Food-Drug Interactions in Bioequivalence
- Formulation Factors Influencing Bioavailability
- Fundamentals of Bioavailability and Bioequivalence Studies
- In Vitro-In Vivo Correlation
- Pediatric and Geriatric Bioequivalence
- Pharmacogenomics and Personalized Medicine
- Pharmacokinetic Parameters and Analysis
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