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Drug dissolution testing and establishing plasma drug levels in humans 2017

Start Date:
Thursday, 26 October, 2017
End Date:
Friday, 27 October, 2017 6:00pm
Oncology, Gastroenterology, Immunology, Hepatology, Endocrinology, Infectious Disease, Pediatrics, Internal Medicine

Course "Drug dissolution testing and establishing plasma drug levels in humans" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Drug dissolution testing is an essential and critical step for appropriate and efficient product development such as tablet and capsule. A number of approaches are used to conduct dissolution testing using different apparatuses and methods.

Making a choice for an appropriate apparatus and method has always been confusing and challenging. This seminar will provide relevant pharmacokinetics and physiological background so that making this choice becomes easier and instinctive. No prior knowledge of pharmacokinetic and/or physiology is required; however, these will be explained in very simple terms to help attendees in selecting or developing a dissolution method.

This seminar will describe in detail the theoretical aspect of the drug dissolution testing including method development. Pros and cons of different approaches will be explained in detail.Furthermore, drug dissolution testing is extensively conducted to provide an estimate/prediction of expected drug levels in humans. Commonly, concepts of convolution/deconvolution and in vitro-in vivo correlation (IVIVC) are described in this respect, unfortunately with limited success.

Difficulties and limitations of the currently suggested approaches will be highlighted. This seminar will provide details of the underlying scientific principles involved in convolution, deconvolution and IVIVC techniques with simple practical examples. In this regard, a unique and simple approach based on convolution technique using spreadsheet software will be described. Why you should attend: Pharmaceutical product developments and assessments require extensive use of in vitro drug dissolution testing and convolution/deconvolution techniques for predicting plasma drug levels.

Often such testing are presented in isolation (independent 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 opportunity to learn scientifically valid drug dissolution testing and establishing plasma drug levels.It would be an unmatched opportunity to learn from an internationally recognized leader of the subject.

A must attend seminar for anyone involved in product developments and assessments of solid oral dosage forms! Areas Covered in the Session: Physiological and Pharmacokinetic Principles:Dissolution and related physiological terms: Drug absorption, permeation, relevant GI tract environment.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.Defining, and differentiating, drugs/medicines and drug/medicinal productsDefining quality of drugs/medicines and drug/medicinal products.Generic vs innovator's products (Similarities and differences) Drug Dissolution Testing: What is drug dissolution Testing and Why to conduct such tests?Dissolution theory, sink conditions and intrinsic dissolution rateDrug Dissolution Testing vs Solubility determinationDrug Dissolution vs Drug Release Testing - Is there a difference?Dissolution Testing Apparatus:Rotating basket (USP Apparatus 1)Rotating paddle (USP Apparatus 2)Reciprocating cylinder (USP Apparatus 3)Flow-through cell (USP Apparatus 4)Non-compendial (Crescent-shape)Setting up a dissolution tester (e.g.

Basket and paddle)Dissolution equipment qualification (Performance Tablets vs Mechanical Calibration)Tolerances and results InterpretationImmediate releaseExtended releaseDelayed releaseCurrent Requirements And InterpretationsDissolution Method DevelopmentsGeneral requirementsSelection of dissolution mediumApparatus and agitation rateSampling (time points & filtration)Acceptance criteria (Pharmacopeial, similarity factor (F2), physiologically relevant, etc.)QC method, bio/clinical relevant methodsDiscriminatory vs non-discriminatory dissolution methodsProduct dependent vs product independent MethodsDissolution 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), their requirements and (un)suitability for predicting plasma drug levelsRequirements for appropriate and relevant dissolution resultsConvolution vs deconvolution methods which one to use and why?Predicting plasma drug levels (Linking dissolution results to physiology)Theoretical backgroundConverting dissolution results into plasma drug levels/profilesPractical application with step-by-step instructionsPractical hands-on interactive demonstration of predicting/estimating of plasma drug levels using Excel spreadsheet software.

Attendees may use their computers as well to follow the instructions for obtaining plasma drug levels. Who will benefit: Anyone 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 DevelopmentSetting up analytical methods (pharmacopeial, regulatory or in-house developed)R & D, both analytical and formulationProject ManagementQuality ControlQuality AssuranceRegulatory Affairs Agenda: Day 1 Schedule Lecture 1: (90 Mins)Physiological and Pharmacokinetic PrinciplesLecture 2: (60 Mins)[Continue] Physiological and Pharmacokinetic Principles (30 Mins) Question/Answer/discussionLecture 3: (90 Mins)Drug Dissolution TestingLecture 4: (60 Mins)[Continue] Drug Dissolution Testing (30 Mins) Question/Answer/discussion Day 2 Schedule Lecture 1: (90 Mins)Linking Dissolution Results to Plasma Drug LevelsLecture 2: (60 Mins)[Continue] Linking Dissolution Results to Plasma Drug Levels (30 Mins) Question/Answer/discussionLecture 3: (90 Mins)Practical hands-on interactive demonstration of predicting/estimating of plasma drug levels using Excel spreadsheet softwareLecture 4: (60 Mins)[Continue] Practical hands-on interactive demonstration of predicting/estimating of plasma drug levels using Excel spreadsheet software (30 Mins) Wrap-up Speaker:Dr.

Saeed QureshiDr. 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. Specifically: (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 ( 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 ( Location: San Diego, CA Date: October 26th & 27th, 2017 and Time: 9:00 AM to 6:00 PMVenue: DoubleTree by Hilton San Diego Downtown 1646 Front St, San Diego, CA 92101, USA Price: Register now and save $200. (Early Bird)Price: $1,295.00 (Seminar Fee for One Delegate)Until September 20, Early Bird Price: $1,295.00 From September 21 to October 24, Regular Price: $1,495.00Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Sponsorship Program benefits for "Quality Assurance Auditing for FDA Regulated Industry" seminar At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO's of various designations.

Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry. As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts.

Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants. For More Information- Contact us today! NetZealous LLC DBA Toll free: +1-800-447-9407Phone: +1-510-584-9661 Website: Registration Link - Follow us on LinkedIn: us our Facebook page: us on Twitter: Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable{mso-style-name:"Table Normal";mso-tstyle-rowband-size:0;mso-tstyle-colband-size:0;mso-style-noshow:yes;mso-style-priority:99;mso-style-parent:"";mso-padding-alt:0in 5.4pt 0in 5.4pt;mso-para-margin-top:0in;mso-para-margin-right:0in;mso-para-margin-bottom:10.0pt;mso-para-margin-left:0in;line-height:115%;mso-pagination:widow-orphan;font-size:11.0pt;font-family:"Calibri","sans-serif";mso-ascii-font-family:Calibri;mso-ascii-theme-font:minor-latin;mso-hansi-font-family:Calibri;mso-hansi-theme-font:minor-latin;}


DoubleTree by Hilton San Diego Downtown

Organizer Details

Conference organized by NetZealous DBA as GlobalCompliancePanel

NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA94539, USA
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