Biopharmaceutical Aspects Of The Active Pharmaceutical Ingredient And Pharmaceutical Equivalence
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 (formerly, Eon Labs). He has over 35 years’ experience in both academia and the pharmaceutical industry. Dr. Shargel has lectured widely on pharmacokinetics, bioavailability and generic drug product development. He has over 200 publications including a leading textbook, “Applied Biopharmaceutics & Pharmacokinetics.” Dr. Shargel received a B.S. in Pharmacy from the University of Maryland and a Ph.D. in Pharmacology from the George Washington University Medical Center. He is a member of various professional societies including the American Association of Pharmaceutical Scientists (AAPS), American Pharmacists Association (APhA) and the American Society for Pharmacology and Experimental Therapeutics (ASPET).
The term, pharmaceutical equivalence, considers both the equivalence of the active pharmaceutical ingredient (API) and the equivalence of the finished dosage form (drug product). Demonstration of pharmaceutical equivalence is a scientific and regulatory challenge. Pharmaceutical equivalent drug products have the same active drug ingredient; same strength; same dosage form and route of administration; comparable labeling and meets compendial or other applicable standards of strength, quality, purity, and identity. Pharmaceutical equivalent drug products may contain different inactive ingredients or excipients, e.g., colorant, flavor, and preservative and may contain different amounts of impurities within an allowable range. Pharmaceutical equivalence does not assure bioequivalent drug product performance. Pharmaceutical equivalent drug products are bioequivalent only if they display comparable bioavailability (rate and extent of drug availability) when studied under similar experimental conditions. 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.
- Define biopharmaceutics and demonstrate how bio pharmaceutics relates to drug product performance, in vivo
- Define active pharmaceutical ingredient, API and drug product (finished dosage form)
- Define pharmaceutical equivalence, pharmaceutical alternative, bioequivalence, and therapeutic equivalence
- Show how the physical and chemical properties of the drug substance and the drug product relate to pharmaceutical equivalence
- Explain how a drug product that is not an exact pharmaceutical equivalent can be a therapeutic equivalent
Who Should Attend
This webinar will be of interest to scientists and managers in the pharmaceutical industry, regulators and other pharmaceutical scientists who want to learn more about the pharmacokinetics of systemic drug absorption and its applications to the development of oral dosage forms.
Pharma (brand) and generic drug companies, faculty and students in the department of pharmaceutical sciences, at various colleges of pharmacy.
- Biopharmaceutics and drug absorption process
- Drug product performance - bioavailability, pharmaceutical equivalence, and bioequivalence
- Drug product quality and performance in drug product development
- Pharmaceutical equivalence of the active pharmaceutical ingredient
- Pharmaceutical equivalence of the drug product
- Therapeutic equivalence
- Scientific and regulatory challenges
- Changes to an approved drug product (SUPAC)
- Biotechnology-derived drug products: Biosimilars