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Drug Dissolution Testing and Establishing Plasma Drug Levels in Humans  

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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

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Seminar Summary:

This is a unique in-depth seminar on the subject not available anywhere else with unmatched coverage of scientific details and addressing regulatory and compendial requirements yet extremely simple to understand. (see full course description)

 

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Training Course Syllabus:


Course Description

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 also 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, along with hands-on exercises, will be described.

This is a unique in-depth seminar on the subject not available anywhere else with unmatched coverage of scientific details and addressing regulatory and compendial requirements yet extremely simple to understand.

Seminar Instructor Dr. 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.

Learning Objectives:

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.

DAY 01(8:30 AM - 4:30 PM)

8:30 am – 9:00 am: Registration, Meet & Greet.
Session 1: Physiological and Pharmacokinetic Principles (90 Mins)
Coffee Break
Session 2: [Continue] Physiological and Pharmacokinetic Principles (60 Mins)
Question/Answer/discussion (30 Mins)
Lunch Break
Session 3: Drug Dissolution Testing (90 Mins)
Coffee Break
Session 4: [Continue] Drug Dissolution Testing (60 Mins)
Question/Answer/discussion (30 Mins)

DAY 02(8:30 AM - 4:30 PM)

Session 1: Linking Dissolution Results to Plasma Drug Levels (90 Mins)
Coffee Break
Session 2: [Continue] Linking Dissolution Results to Plasma Drug Levels (90 Mins)
Question/Answer/discussion (30 Mins)
Lunch Break
Session 3: Practical hands-on interactive demonstration of predicting/estimating of plasma drug levels using Excel spreadsheet software (90 Mins)
Coffee Break
Session 4: Practical hands-on interactive demonstration of predicting/estimating of plasma drug levels using Excel spreadsheet software (60 Mins)
Wrap-up (15 Mins)

Seminar Summary:

This is a unique in-depth seminar on the subject not available anywhere else with unmatched coverage of scientific details and addressing regulatory and compendial requirements yet extremely simple to understand. (see full course description)

print this agenda print agenda for the Drug Dissolution Testing and Establishing Plasma Drug Levels in Humans training seminar

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