Predicting Plasma Drug Levels and Relevant Concepts of Convolution/Deconvolution and In Vitro-In Vivo Correlations (IVIVC)

Why Should You Attend:

Drug dissolution testing is an essential and critical step for an appropriate and efficient product development such as tablets and capsules. A desired objective during product development stage is that drug dissolution testing to provide an estimation/prediction of expected drug levels in humans. Commonly, concepts of convolution/deconvolution and IVIVC are described in this respect, unfortunately with limited or no success.

This webinar will describe difficulties and limitations of the currently suggested approaches, leading to a very simple approach and method for predicting plasma drug levels. It is a relatively simple mathematical conversion step using some basic pharmacokinetic parameters. Importantly, such estimations/predictions do not require concurrent IVIVC studies and are product independent.

Attendees will learn how such method can be established using simple and unique approach based on excel spreadsheet software. The relevant pharmacokinetics and physiological concepts will be explained in such a manner that need for prior knowledge of these will be minimal. A must to attend for anyone involved in product developments and assessments of solid oral dosage forms.

Areas Covered in the Webinar:

• Drug absorption process from the gastrointestinal (GI) tract including terminologies such as absorption, permeation, dissolution and related physiological terms
• 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.
• Concepts of convolution, deconvolution and in vitro in vivo correlation (IVIVC), their requirements and (un)suitability for predicting plasma drug levels
• Requirements for appropriate and relevant dissolution results
• Converting dissolution results into plasma drug levels/profiles, step-by-step instructions
• Practical demonstration of predicting/estimating of plasma drug levels using excel spreadsheet software. Attendees may use their computers as well to follow up the instructions for obtaining plasma drug levels.

Who Will Benefit:

This webinar will provide valuable assistance to personnel working as bench chemist/analyst, supervisor, managers, director or vice president in pharmaceutical manufacturing facilities, including laboratories and associated contract organizations, of innovator and generic companies for human and animal products, in the following areas:

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

Saeed Qureshi
Principal, PharmacoMechanics

Dr. Saeed Qureshi has extensive (30+ years) working experience, as a research scientist, with 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. His areas of expertise include: (1) Quality assessment of pharmaceutical products based on pharmacokinetic studies (e.g. bioavailability/bioequivalence) in humans and animals, including validation of in vitro results with in vivo (bioavailability) studies. (2) In vitro drug release characterization of pharmaceutical products in particular oral and dermal using dissolution and/or diffusion (absorption/penetration through skin) techniques. (3) Analytical methods development/validation for drug disposition evaluation in humans and animals using chromatographic (e.g. HPLC, GC, TLC) and spectroscopic (e.g. UV, MS) techniques. (4) Data analysis using sophisticated (SAS) and general-purpose (e.g. MS Excel) software.

Dr. Qureshi has extensively published in peer-reviewed journals and given numerous national and international presentations on the subject. Dr. Qureshi is very well known for his innovative but simple and practical ideas. Since 2010, he has been contributing and moderating a weblog (www.drug-dissolution-testing.com) which has become a popular source of new and thought provoking ideas for addressing the issues of product evaluations.

Since 2015 Dr. Qureshi has been working as an independent consultant. A detailed description of his expertise and the services he provides may be obtained from the website (www.pharmacomechanics.com).

Topic Background:

Pharmaceutical product developments and assessments require extensive in vitro drug dissolution testing. The main purpose of conducting such testing is to assess in vivo (or physiological) behavior of the products in particular tablet and capsule establishing their quality. The only way this can be assessed is by estimating potential plasma drug concentration-time profiles from in vitro dissolution results.

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