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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