Pharmacokinetics/Biopharmaceutics for Chemists/Analysts

Why Should You Attend:

Pharmaceutical product developments and assessments require extensive analytical data to establish quality, safety and efficacy of the products. These data are generated by laboratory facilities (internal as well as external to manufacturers) which often lack needed physiological and biological expertise/understanding leading to poor study or experimental design followed by inaccurate interpretation of results. Therefore, current practices are not only causing significant waste of time and frustration within industry and regulatory authorities but delays in product approvals and financial losses for the manufacturers. This webinar is designed to address these deficiencies.

The attendees will have clear understanding of underlying science so that they would be able design the experimental studies appropriately followed by efficient and accurate interpretation of the results. Differences in drugs/medicines and their products will be explained so that kinetic models can be applied appropriately. Terminologies commonly used will be explained in detail with an overview of applicable regulatory requirements and practices.

Areas Covered in the Webinar:

• Describing and defining pharmacokinetics and biopharmaceutics
• Overview of relevant cardiovascular and gastrointestinal physiology
• Importance and necessity of clear understanding of relevance of physiology and pharmacokinetics for analysts
• Differentiating drugs/medicines from drug/medicinal products concerning safety, efficacy and quality aspects
• Describing journey of a drug through the body and its compartmentalization
• Explaining commonly used terminologies-I: drug absorption, distribution, metabolism and elimination
• Explaining commonly used terminologies-II: plasma drug concentration-time profile, area under the curve (AUC), Cmax, Tmax, apparent volume of distribution, elimination rate constant, half-life
• Assessment of drug products: Innovators vs generic, concepts of bioavailability/bioequivalence, in vitro-in vivo evaluations
• Overview of regulatory requirements and guidance’s

Who Will Benefit:

This webinar will provide valuable assistance to personnel working as bench chemist/analyst, supervisor, manager, 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 Control
• 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).

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