Biowaivers
Biowaivers are regulatory exemptions granted for certain bioequivalence studies, allowing for the approval of generic drugs without conducting comparative clinical trials. They are typically based on the demonstration of similarity in the rate and extent of drug absorption between the generic and reference products using in vitro dissolution testing or other surrogate measures. Biowaivers are granted when the drug's pharmacokinetics are well understood, and there is a high likelihood of therapeutic equivalence, saving time and resources in drug development while maintaining patient safety and efficacy.
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Biowaivers 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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