Regulatory Requirements for Bioequivalence
The bioequivalence for oral drug is determined by contrast the relative bioavailability of the logo drug compared to the generic drug. Food effect bioavailability are commonly conducted for new drugs and drug effect during the investigational new drug (IND) phase to assess the effects of food on the rate and proportions of engrossment of a drug when the drug product is management shortly after a meal fed conditions, as compared to commanding under diet conditions
- WHO Approaches
- FDA Approach and regulations
- TGA and risk management approach
- Food-Effect Bioavailability and Fed Bioequivalence Studies
- European Guidelines
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Regulatory Requirements for Bioequivalence Conference Speakers
Recommended Sessions
- BA/BE studies of Biologics and Biosimilars
- BCS & IVIVC Based Bio waivers
- Bioavailability
- Bioequivalence
- Bioequivalence Protocols: In vivo/ In vitro studies
- Biosimilars
- Challenges in Drug Design and Development
- Clinical Pharmacology and Therapeutics
- Clinical Research Vs Clinical Trails
- Clinical Trails
- Drug Metabolism
- Drug Safety
- Factors Affecting Bioavailability
- Pharmaceutical Formulations
- Pharmacology- PK & PD approach
- Recent approaches to Biosimilars
- Regulatory Requirements for Bioequivalence
- Significance of BA/BE Studies
- Study Designs
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- 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)