Biopharmaceutical Aspects of the Active Pharmaceutical Ingredient and Pharmaceutical Equivalence
Duration : 90 Minutes
Leon Shargel,
Leon Shargel, Ph.D., R.Ph., is Manager and Founder of Applied Biopharmaceutics LLC, a pharmaceutical consulting company and holds academic appointments as Affiliate Professor, School of Pharmacy, Virginia Commonwealth University. Prior to forming his own company, Dr. Shargel was Vice President, Biopharmaceutics, Sandoz (formerl Read more
Biopharmaceutics is the study of the physicochemical properties of the drug and the drug product, in vitro, and its relationship to the bioavailability of the drug, in vivo. Bioavailability is the measurement of the rate and extent of active drug that becomes available at the site of action. Biopharmaceutics links the physical and chemical properties of the drug substance and the dosage form to clinical performance. Application of biopharmaceutics allows for the rationale design of new and generic drug products.
This webinar will demonstrate the importance of pharmaceutical equivalence of both the active pharmaceutical ingredient and the drug product in establishing bioequivalence and therapeutic equivalence.
Course Objectives:
• Define biopharmaceutics and show how biopharmaceutics links the physical and chemical properties of the drug substance and the dosage form to clinical performance
• Define active pharmaceutical ingredient, API and drug product (finished dosage form).
• Define pharmaceutical equivalence, pharmaceutical alternatives and therapeutic equivalence .
• Describe the physical and biopharmaceutical properties of API important in the design, and performance of drug products
• Explain the relationship of pharmaceutical equivalence, bioequivalence and therapeutic equivalence
• Explain whether a generic drug product that is not an exact pharmaceutical equivalent can be therapeutic equivalent
• Explain why a generic drug product with identical pharmaceutical equivalence may not lead to equivalent pharmacokinetic and pharmacodynamic performance.
• Explain how size, shape, and other physical attributes of generic tablets and capsules
Course Outline:
• Biopharmaceutics and the relationship of biopharmaceutics to drug product design
• Pharmaceutical equivalence, bioequivalence and therapeutic equivalence.
• Pharmaceutical equivalence of the active pharmaceutical ingredient
• Pharmaceutical equivalence of the drug product
• Explain whether a generic drug product that is not an exact PE can be TE
• Explain why a generic drug product with identical PE may not lead to equivalent pharmacokinetic and pharmacodynamic performance.
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
This webinar will be of interest to:
• Scientists and managers in the pharmaceutical industry
• Pharmaceutics graduate students and faculty and other pharmaceutical scientists
• Process Design Personnel
• Quality Control Analyst
• Quality Assurance Personnel
• Lab Management
• Stability Personnel
• Manufacturing Personnel
• Shipping and Distribution Personnel
• Regulatory Affairs
• Drug Packaging Personnel
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
