Biowaiver
In vivo bioavailability and/or bioequivalence investigations may be waived with a Biowaiver (not considered necessary for product approval). A dissolution test could be used as a surrogate basis for determining whether two medicinal items are equal instead of expensive and time-consuming in vivo trials. At the time, the Biowaiver was only used for pharmaceutical scale-up and post-approval adjustments (SUPAC).
- High Solubility. High Permeability
- Low solubility. High Permeability
- High Solubility. Low Permeability
- Low Solubility. Low Permeability
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Biowaiver Conference Speakers
Recommended Sessions
- Biologic Drugs
- Biological Medicines
- Biowaiver
- Current Issues in Bioavailability and Bioequivalence
- Drug Elimination
- Food and Drug Administration
- Forms of Drug Delivery System
- Nanoparticles- An Innovative Drug Delivery System
- Pharma Innovations in 21st century
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- Regulatory Sciences
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- The Chemistry of Food
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