BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T145709Z UID:b549be1a-2438-491f-828c-6bc3d623df88 DTSTART:20210205T090000 DTEND:20210206T090000 CLASS:PRIVATE DESCRIPTION:
Drug dissolution testing is an essential and critical step f or appropriate and efficient product development such as tablet and capsul e. A number of approaches are used to conduct dissolution testing using di fferent apparatuses and methods. Making a choice for an appropriate appara tus and method has always been confusing and challenging. This seminar wil l provide relevant pharmacokinetics and physiological background so that m aking this choice becomes easier and instinctive. No prior knowledge of ph armacokinetic and/or physiology is required\; however\, these will be expl ained in very simple terms to help attendees in selecting or developing a dissolution method. This seminar will describe in detail the theoretical a spect of the drug dissolution testing including method development. Pros a nd cons of different approaches will be explained in detail.
\n\nFur thermore\, drug dissolution testing is extensively conducted to provide an estimate/prediction of expected drug levels in humans. Commonly\, concept s of convolution/deconvolution and in vitro-in vivo correlation (IVIVC) ar e described in this respect\, unfortunately with limited success. Difficul ties and limitations of the currently suggested approaches will be highlig hted. This seminar will provide details of the underlying scientific princ iples involved in convolution\, deconvolution and IVIVC techniques with si mple and practical examples. In this regard\, a unique and simple approach based on convolution technique using spreadsheet software will be describ ed.
\n\nPharmaceutical pr oduct developments and assessments require extensive use of in vitro drug dissolution testing and convolution/deconvolution techniques for predictin g plasma drug levels. Often such testing are presented in isolation (indep endent to their physiological link or relevance)\, however\, this seminar will train attendees for developing these techniques using the principles of pharmacokinetics and physiology. The seminar will provide unique opport unity to learn scientifically valid drug dissolution testing and establish ing plasma drug levels.
\n\nIt would be an unmatched opportunity to learn from an internationally recognized leader of the subject. A must att end seminar for anyone involved in product developments and assessments of solid oral dosage forms!
\n\nPhy siological and Pharmacokinetic Principles
\n\n[Continue] \;Physiological and P harmacokinetic Principles
\n(30 Mins): Question/Answer/discuss ion\n\nDrug Dissolution Testing
\n\n[Continue] \;Drug Dissolution Testing
\n(30 Mins): Question/Answe r/discussion\n\nLinking Dissolution Results to Plasma Drug Levels
\n\n[Continue] \;Lin king Dissolution Results to Plasma Drug Levels
\n(30 Mins): Qu estion/Answer/discussion\n\nPractic al hands-on interactive demonstration of predicting/estimating of plasma d rug levels using Excel spreadsheet software
\n\nPractical hands-on interactive demonstration of p redicting/estimating of plasma drug levels using Excel spreadsheet softwar e
\n(30 Mins): Wrap-up \;Dr. Qureshi has extensive (30+ years) working experience\ , as a research scientist\, with a regulatory agency (Health Canada). He i s an internationally known expert on the subject and maintains a full comm and in the areas of drug dissolution testing\, pharmacokinetics\, biopharm aceutics and analytical chemistry as related to animal and human studies f or developing and evaluating pharmaceutical products. Specifically: (1) Qu ality assessment of pharmaceutical products based on pharmacokinetic studi es (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 par ticular oral and dermal using dissolution and/or diffusion (absorption/pen etration through skin) techniques. (3) Analytical methods development/vali dation for drug disposition evaluation in humans and animals using chromat ographic (e.g. HPLC\, GC\, TLC) and spectroscopic (e.g. UV\, MS) technique s. (4) Data analysis using sophisticated (SAS) and general-purpose (e.g. M S Excel) software.
\n\nDr. Qureshi has extensively published in peer -reviewed journals and given numerous national and international presentat ions on the subject. Dr. Qureshi is very well known for his innovative but simple and practical ideas. Since 2010\, he has been contributing and mod erating a weblog (www.drug-dissolution-testing.com) which has become a pop ular source of new and thought provoking ideas for addressing the issues o f product evaluations.
\n\nSince 2021 Dr. Qureshi has been working a
s an independent consultant. A detailed description of his expertise and t
he services he provides may be obtained from the website (www.pharmacomech
anics.com).
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