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
Related Conference of Biowaiver
November 20-21, 2024
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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
- Protein Interactions as Targeted Therapeutics
- Regulatory Sciences
- Solubility Enhancement
- The Chemistry of Food
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- Real-World Evidence in Clinical Trials - Pharma Europe 2025 (Italy)
- Recent Advancements in Medicinal Pharma - PHARMA MEDICINAL CHEMISTRY 2025 (Canada)
- Recent advances in drug delivery - Drug Devilvery 2024 (UAE)
- Reformulation Research - Drug Safety 2024 (France)
- Regenerative Medicine and Tissue Engineering - Drug Delivery-2024 (France)
- Regulatory affairs - Pharmacoepidemiology Congress 2024 (Canada)
- Regulatory Affairs and Drug Safety - PHARMACEUTICAL CHEMISTRY 2025 (Italy)
- Regulatory Affairs and Intellectual Property Rights - Future Pharma 2025 (Netherlands)
- Regulatory Affairs and Quality Assurance in Pharmaceutics - Pharmaceutica-2025 (Canada)
- Regulatory Authority Compliance - MedTech-2024 (Switzerland)
- Regulatory Considerations in Drug Development - Drug Delivery-2024 (France)
- Regulatory Requirements for Pharmaceuticals - PHARMACEUTICAL SCIENCES 2025 (France)
- Regulatory Updates on Biosimilars - Eurobiosimilars 2025 (France)
- Research and development in pharmaceuticals - Drug Safety 2024 (France)
- Research and Trials on Oncology and AIDS - Clinical-Trials-2024 (Canada)
- Risk Management - Pharmacoepidemiology Congress 2024 (Canada)
- Safety of drugs and pharmacovigilance - Drug Safety 2024 (France)
- Smart Drug Delivery Systems - Pharmatech 2025 (Canada)
- Smart Polymers for Drug Delivery - Pharmaceutica-2025 (Canada)
- Sustainability and Global Health Biotechnology - Biotech-2025 (France)
- Synthetic and Bioorganic Chemistry - PHARMACEUTICAL CHEMISTRY 2025 (Italy)
- Targeted Drug Delivery and Controlled Release Systems - PHARMA CONFERENCE-2025 (Czech Republic)
- Targeted Therapies - Personalizedmedicine-2024 (Switzerland)
- Technologies for Formulation - Drug Safety 2024 (France)
- Technology in Pharma Sciences - MedTech-2024 (Switzerland)
- Telemedicine - Personalizedmedicine-2024 (Switzerland)
- The BBB for drug delivery - Drug Safety 2024 (France)
- The Future of Pharma R&D - Future Pharma 2025 (Netherlands)
- The Next Generation Approach of Antibiotics - Antibiotics Resistance 2024 (Canada)
- Therapeutic Drug Transporters - Drug Safety 2024 (France)
- Translational Research - Personalizedmedicine-2024 (Switzerland)
- Translational Research in Pharmacology and Therapeutics - NURSING PHARMACOLOGY 2024 (Netherlands)
- USFDA Approved Biosimilars - Eurobiosimilars 2025 (France)
- Vaccine Delivery Systems - Pharmaceutica-2025 (Canada)
- Vaccine Design and Drug Design - PHARMA CONFERENCE-2025 (Czech Republic)
- Wearable Drug Delivery Systems - PHARMA CONFERENCE-2025 (Czech Republic)