Biopharmaceutic Considerations in Drug Product Design and In Vitro Drug Product Performance
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
This webinar will examine the rational use of biopharmaceutical principles to design a drug product that will optimize drug delivery to achieve the therapeutic objectives of the drug.
Course Objectives:
Bioavailability is a measurement of the rate and extent of active drug that becomes available at the site of action. For oral drug products, the drug must be absorbed systemically to achieve the desired therapeutic effect. 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 drug products.
This webinar will demonstrate how biopharmaceutics may be used in the rational design of a drug product to achieve a desired therapeutic objective. Furthermore, the webinar will discuss the measurement of drug product performance, in vitro, including drug dissolution and in vitro in vivo correlation.
Participants will be introduced to the basic concepts of biopharmaceutics and apply these principles to the design of finished dosage forms (drug products). Participants will learn how the physicochemical properties of the drug substance and the formulation of the drug product affect drug product performance. In addition, participants will consider the rate-limiting steps in drug absorption, the quantitative measurement of in vitro performance using dissolution and drug release testing and the determination of In Vitro–In Vivo Correlation.
Course Outline:
• Biopharmaceutic Factors and Rationale for Drug Product Design
• Rate-Limiting Steps in Drug Absorption
• Physicochemical Properties of the Drug
• Formulation Factors Affecting Drug Product Performance
• Drug Product Performance, In Vitro: Dissolution and Drug Release Testing
• Compendial Methods of Dissolution
• Alternative Methods of Dissolution Testing
• Dissolution Profile Comparisons
• Meeting Dissolution Requirements
• Problems of Variable Control in Dissolution Testing
• Performance of Drug Products: In Vitro–In Vivo Correlation
• Approaches to Establish Clinically Relevant Drug Product Specifications
• Drug Product Stability
• Considerations in the Design of a Drug Product
• Drug Product Considerations
What You Get:
• Training Materials
• Live Q&A Session with the Speaker
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
The following personnel in pharmaceutical Industry will benefit from this training:
• Scientists and managers in the pharmaceutical industry
• Product development
• Quality Control and Research
• Faculty
• Process Design Personnel
• Quality Control Analyst
• Quality Assurance Personnel
• Lab Management
• Manufacturing Personnel
• Shipping and Distribution Personnel
• Regulatory Affairs
• Pharmaceutics graduate students and faculty and other pharmaceutical scientists
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
