Bioavailability & Bioequivalence studies of Biopharmaceuticals
The assessment of BA/BE of different drug products is based on the fundamental assumption that two products are equivalent when 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 when administered at the same molar dose of the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses. Should the rate of absorption actually differ between products, it would have to be intentional and reflected in the proposed product label and be clearly demonstrated that it is not essential in the attainment of effective body drug concentrations on chronic use or has been shown to be medically insignificant for the drug. In practice, equivalence is indicated when key pharmacokinetic parameters used to establish rate and extent of the test, and reference products fall within a present confidence interval. The FDA declares a drug product to be therapeutically equivalent to the innovator product if it is pharmaceutically equivalent, i.e., same active ingredient, dosage form, strength and route of administration, and bioequivalent. Products that are therapeutically equivalent can be used interchangeably. Thus, BE studies are construed to be considered surrogates for comparative clinical trials for the assessment of therapeutic equivalence in safety and efficacy between two drug products.
- Drug Absorption and Distribution
- Bioequivalence Protocols : In vitro-In vivo correlation
- Dissolution Studies
- PK/PD studies
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- Pharmacology of Addiction and Substance Abuse - Pharmacology-2024 (France)
- Pharmacology of Aging and Geriatric Medicine - Pharmacology-2024 (France)
- Pharmacology of Antimicrobial Resistance - Pharmacology-2024 (France)
- Pharmacology of Cancer Immunotherapy - Pharmacology-2024 (France)
- Pharmacology of Cardiovascular Therapeutics - Pharmacology-2024 (France)
- Pharmacology of Neurodegenerative Disorders - Pharmacology-2024 (France)
- Pharmacology of Nutraceuticals and Dietary Supplements - Pharmacology-2024 (France)
- Pharmacology of Pain Management and Analgesia - Pharmacology-2024 (France)
- Pharmacology of Rare Diseases - Pharmacology-2024 (France)
- Pharmacology of Respiratory Diseases: - Pharmacology-2024 (France)
- Pharmacovigilance and Drug Safety - Clinical-Trials-2024 (Canada)
- Pharmacovigilance and Drug Safety - PHARMA CONFERENCE-2025 (Czech Republic)
- Pharmacovigilance in the Era of Big Data - Pharmacology-2024 (France)
- Pharmacy Development Services - Pharma Europe 2025 (Italy)
- Pharmacy Education and Practice - PHARMACEUTICAL SCIENCES 2025 (France)
- Photochemistry and Phytopharmaceuticals - PHARMAKON 2025 (Spain)
- Phytochemistry - Natural Products 2024 (Italy)
- Population Health - Personalizedmedicine-2024 (Switzerland)
- Post-Marketing Surveillance Insights - Clinical Trials Congress-2025 (France)
- Post-Trial Closed Communities - Clinical Trials Congress-2025 (France)
- Precision Medicine - Personalizedmedicine-2024 (Switzerland)
- Precision Medicine and Pharmacogenomics - NURSING PHARMACOLOGY 2024 (Netherlands)
- Public Health and Community Nursing - NURSING PHARMACOLOGY 2024 (Netherlands)
- Purpose and Principles of GMP - PHARMACEUTICAL SCIENCES 2025 (France)
- QC & QA: Quality control and Quality assurance - MedTech-2024 (Switzerland)
- Quality by design(QbD) approach - MedTech-2024 (Switzerland)
- Quality Control and Regulatory Considerations in Drug Delivery Systems - Pharmaceutica-2025 (Canada)
- 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)
- Reformulation Research - Drug Safety 2024 (France)
- Regenerative Medicine and Tissue Engineering - Drug Delivery-2024 (France)
- 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)
- Role of Gut Microbiome in Cardiovascular Health - Cardiovascular-2025 (France)
- Role of Inflammation in Cardiovascular Diseases - Cardiovascular-2025 (France)
- 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)
- Targeted Therapies in Cardiovascular Regeneration - Cardiovascular-2025 (France)
- Targeting the Renin-Angiotensin-Aldosterone System (RAAS) - Cardiovascular-2025 (France)
- 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)
- Vascular Pharmacology: Focus on Endothelial Dysfunction - Cardiovascular-2025 (France)
- Wearable Drug Delivery Systems - PHARMA CONFERENCE-2025 (Czech Republic)