Drug Dissolution Testing and Establishing Plasma Drug Levels in Humans 2018

Topics

• Basic and required pharmacokinetic principles including terminologies such as plasma drug concentration-time profiles/curves, rates of absorption and elimination, Cmax, Tmax, half-life, AUC, apparent volume of distribution, bioavailability/bioequivalence, etc
• Dissolution and related physiological terms: Drug absorption, permeation, relevant GI tract environment
• Defining quality of drugs/medicines and drug/medicinal products
• Defining, and differentiating, drugs/medicines and drug/medicinal products
• What is drug dissolution Testing and Why to conduct such tests?
• Generic vs innovator`s products (Similarities and differences)
• Drug Dissolution Testing vs Solubility determination
• Dissolution theory, sink conditions and intrinsic dissolution rate
• Dissolution Testing Apparatus
• Drug Dissolution vs Drug Release Testing - Is there a difference?
• Dissolution equipment qualification (Performance Tablets vs Mechanical Calibration)
• Setting up a dissolution tester (e.g. Basket and paddle)
• Dissolution Method Developments
• Tolerances and results Interpretation
• Linking Dissolution Results to Plasma Drug Levels

Who should Attend

Attendees with responsibilities in:

• Setting up analytical methods (pharmacopeial, regulatory or in-house developed)
• Pharmaceutical Development
• Project Management
• R & D, both analytical and formulation
• Quality Assurance
• Quality Control
• Regulatory Affairs