Drug dissolution testing and predicting human plasma drug profiles (2-day in-person seminar)

Background:

Drug dissolution testing is an essential and critical step for appropriate and efficient development and manufacturing of products such as tablet and capsule. To conduct such studies and relating the outcome to in vivo (human bioavailability/bioequivalence studies) require understanding of relevant pharmacokinetics and human physiology which is often missed. This seminar will focus on fulfilling this gap for conducting scientifically and physiologically (also known as bio-/clinically) relevant dissolution tests. No prior knowledge of pharmacokinetics and/or physiology is required; however, these will be explained with an amazing simplicity and clarity. Commonly referred concepts of convolution/deconvolution and in vitro-in vivo correlation (IVIVC) will be explained in detail leading to description of a methodology, with hands-on exercises, for predicting plasma drug profiles from dissolution results using Excel spreadsheet software.

Who should attend:

Anyone working within the pharmaceutical manufacturing areas in particular for tablet/capsule, specifically in the areas of formulation and product development, related analytical laboratories, R & D, project management, quality control/assurance, regulatory affairs.

Instructor:

Dr. Saeed Qureshi – an internationally recognized and an award winning scientist with 30+ years of working experience in a regulatory agency (Health Canada). He is an internationally known expert on the subject and maintains a full command in the areas of drug dissolution testing, pharmacokinetics, biopharmaceutics and analytical chemistry as related to animal and human studies for developing and evaluating pharmaceutical products. Complete details about Dr. Qureshi experience and expertise could be found here (http://www.pharmacomechanics.com/expertise.html).

Seminar (Course) Details:

Physiological and Pharmacokinetic Principles:

• Related physiological terms: GI tract environment, drug absorption, permeation.
• Pharmacokinetic principles including terminologies of plasma drug concentration-time profiles/curves, rates of absorption and elimination, Cmax, Tmax, half-life, AUC, apparent volume of distribution, bioavailability/bioequivalence, etc.
• Defining, and differentiating, drugs/medicines and drug/medicinal products
• Defining quality of drugs/medicines and drug/medicinal products.

Drug Dissolution Testing:

• Theoretical concepts
• Drug Dissolution Testing vs Solubility determination
• Drug Dissolution vs Drug Release Testing – Is there a difference?
• Apparatuses: compendial vs non-compendial
• Apparatus/instruments qualification/calibration
• Results Interpretation and tolerance
• Dissolution Method Developments
  • Apparatus and agitation rate
  • Selection of dissolution medium
  • Sampling and run times
  • QC method, bio/clinical relevant methods
  • Discriminatory vs non-discriminatory methods
  • Product dependent vs product independent methods
  • Dissolution method validation vs analytical (quantitation) method validation
  • (Specificity, Linearity/range, Accuracy/recovery, Precision, Robustness)

Linking Dissolution Results to Plasma Drug Levels:

• Concepts of convolution, deconvolution and in vitro in vivo correlation (IVIVC)
• Requirements for appropriate and relevant dissolution results
• Convolution vs deconvolution methods which one to use and why?
• Predicting plasma drug levels (theoretical background)

Practical hands-on interactive demonstration of predicting/estimating of plasma drug levels using Excel spreadsheet software. Attendees should bring their computers for hands-on practice.