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
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- Drug Elimination
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- The Chemistry of Food
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- Stem Cell and Genetic Clinical Research - Clinical Research 2026 (UK)
- Stewardship Programs in Human and Animal Health - Euro Antibiotics 2025 (Netherlands)
- Structure-Based Drug Design and Molecular Docking - Euro MedChem and CADD 2025 (France)
- Supply Chain Management - Pharmaceuticals-2025 (France)
- Sustainable Antibiotic Practices and Global Policy - Euro Antibiotics 2025 (Netherlands)
- Sustainable Biologics Manufacturing - Biologics Meet 2026 (UK)
- Synthetic and Bioorganic Chemistry - PHARMACEUTICAL CHEMISTRY 2025 (France)
- Synthetic and Green Medicinal Chemistry - Euro MedChem and CADD 2025 (France)
- Systems Pharmacology and Drug Modeling - Euro Pharmacology 2025 (France)
- Target Identification and Validation - Euro MedChem and CADD 2025 (France)
- Targeted Drug Delivery and Nanomedicine in Infectious Diseases - Euro Antibiotics 2025 (Netherlands)
- Targeted Therapies - Personalizedmedicine-2025 (Switzerland)
- Technology in Pharma Sciences - MedTech-2025 (Switzerland)
- Telemedicine - Personalizedmedicine-2025 (Switzerland)
- The Role of CROs in Clinical Trial Execution - Clinical Trials-2026 (UK)
- Toxicological Impacts of Air and Water Pollution - Euro Pharmacology 2025 (France)
- Toxicology - Pharmacology 2026 (Italy)
- Toxicology and Safety Pharmacology - Pharmacology-2025 (Germany)
- Toxicology: Mechanisms and Risk Assessment - Euro Pharmacology 2025 (France)
- Translational Research - Personalizedmedicine-2025 (Switzerland)
- Types of Formulations - Formulations 2025 (France)
- USFDA Approved Biosimilars - Eurobiosimilars 2026 (Italy)
- Vaccine Development Against Bacterial Pathogens - Euro Antibiotics 2025 (Netherlands)
- Vaccines & Immunotherapy - Pharma Expo-2026 (Thailand)
- Veterinary Pharmacology - Pharmacology-2025 (Germany)