Current Issues in Bioavailability and Bioequivalence
When administered at the same molar dose of the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses, the rate and extent of absorption of the test drug does not show a significant difference from the rate and extent of absorption of the reference drug. Should the rate of absorption varies amongst products, it must be deliberate and stated in the proposed product label, and it must be clearly proved that it is not necessary for achieving effective body drug concentrations on chronic usage or that it is medically irrelevant for the drug. In practise, equivalence is defined as when key pharmacokinetic parameters required to determine the rate and scope of the test, as well as reference products, fall within a predetermined confidence interval. If a drug product is pharmaceutically comparable to the innovator product, meaning it has the same active ingredient, dosage form, strength, and method of administration, and is bioequivalent, the FDA determines it to be therapeutically equivalent. Therapeutically identical products can be used interchangeably. As a result, BE studies are viewed as surrogates for comparative clinical trials in order to determine therapeutic equivalence in terms of safety and efficacy between two pharmacological candidates.
- Biotransformation
- Physico-chemical factors
- Energy dependent efflux transporters
- CYP450 isozymes
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- R&D Advancement: Road to New Medicines - PHARMACEUTICAL SCIENCES 2025 (France)
- Radiation-based medicines and biotherapy - Drug Safety 2024 (France)
- Rational Design of Non-Oral Drugs - PHARMA MEDICINAL CHEMISTRY 2025 (Canada)
- Rational Drug Design and Molecular Modeling - PHARMA CONFERENCE-2025 (Czech Republic)
- 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)