2018 - Understanding in Vitro-in Vivo Correlations Seminar 2018

Overview:
Let us start with a simple question, why would anyone need an IVIVC and prediction of plasma drug levels. The simple answer is that it is the only scientific tool available to the formulators to develop pharmaceutical products such as tablet and capsule accurately and efficiently. Preparing a formulation/product for safety and efficacy assessment and then for general use, it has to be ascertained that a product is capable of delivering the drug in humans as expected. In addition, after developing a product, a relevant in vitro test in the only tool available to establish quality, and extension safety and efficacy, of the product thus link of such test to IVIVC is crucial. Therefore, consideration of IVIVC is perhaps the most critical step in the manufacturing of pharmaceuticals. The regulatory authorities worldwide require practicing and implementation of IVIVC as an integral part of drug applications reviews for product marketing approvals. However, unfortunately, development of IVIVC and its applications have not been as successful as anticipated, more accurately failed, thus leaving the manufacturers and regulatory authorities alike in an extremely confused state for assessing or establishing quality of pharmaceutical products.
Experience of the past 30+ years working in the regulatory environment provided a unique insight of the issues currently facing the industry and regulatory authorities in this regard. This seminar will describe the issues and the reasons which have caused and/or causing the issues. In short, it is the misunderstanding of the scientific concepts as well as the use and requirements of inappropriate experimental conditions and the study designs which are causing the current problems. This seminar will provide simple and practical solutions to address the issues by explaining in detail the underlying scientific concepts and principles which are often missed or overlooked.
Areas Covered in the Session:
• Physiological aspect
• Relevant pharmacokinetics
• Quality, safety and efficacy aspects of drugs/medicines vs drug/medicinal products
• Bioavailability/ bioequivalence
• In vivo and in vitro testing
• Relating/linking in vitro & in vivo outcomes (IVIVC)
• Biopharmaceutic Classification System (BCS)
• Bio-waivers; predicting plasma drug profiles
• Convolution/deconvolution techniques
Who will benefit:
Regulatory affair personnel, bench chemists/analysts, supervisors, managers, directors or vice presidents 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
Agenda:
Day 1 Schedule
Lecture 1:
Background information
• Physiological aspect: Basic physiological concepts; systemic blood circulation; drug absorption, distribution, metabolism and elimination processes
• Pharmacokinetics: Plasma drug concentration-time profiles, Tmax, Cmax, AUC, rate constant, half-life etc.)
• Mathematical and statistical aspects for modelling/predictions: Do not need these, why? Explained!
Morning Coffee Break
Lecture 2:
In vivo testing
• Drugs/medicines vs drug/medicinal products
• Quality, safety and efficacy
• Bioavailability
• Bioequivalence
Lunch Break
Lecture 3:
In vivo testing (continue)
• A model study protocol and its requirements
• Regulatory compliance requirements
In vitro testing
• Drug dissolution/release: Apparatuses, experimental conditions and designs
• Regulatory compliance and pharmacopeial requirements
• Difficulties in obtaining relevant and valid dissolution results
• QC vs bio-/clinically relevant dissolution tests
Afternoon Coffee Break
Lecture 4:
In vivo testing (continue)
• Discriminatory dissolution tests
• Suggested solutions to address current deficiencies
o Alternate approaches
o Universal dissolution tester/tests
Each section includes 15 to 30 minutes of Q&A, discussion and/or hands-on exercise as appropriate
Day 2 Schedule
Lecture 1:
Relating in vitro & in vivo outcomes (IVIVC)
• Why need IVIVC – overview
• Suggested approaches (convolution/de-convolution)
• Pharmacokinetic model based
• Statistical/mathematical (linear system analysis) approach
Lecture 2:
Relating in vitro & in vivo outcomes (IVIVC) [Continue]
• Regulatory compliance requirements
• IVIVC levels
• Biopharmaceutic Classification System (BCS) and its inadequacy
• Bio-waivers
Lecture 3:
Relating in vitro & in vivo outcomes (IVIVC) [Continue]
• Where did it (IVIVC) go wrong?
o IVIVC vs IVIVA (i.e. in vitro-in vivo association)
o Bringing it (IVIVC) back on track – do not need it, why? Explained.
• What is needed - prediction of plasma blood levels?
Lecture 4:
Predicting Plasma drug levels
• Convolution approach for converting dissolution results to plasma profiles.
• Examples
Overall summary
Each section includes 15 to 30 minutes of Q&A, discussion and/or hands-on exercise as appropriate
Speaker:
Dr. Saeed Qureshi
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. 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 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).
Location: Baltimore, MD Date: April 5th & 6th, 2018 Time: 9:00 AM to 6:00 PM
Venue: The DoubleTree Baltimore-BWI Airport 890 Elkridge Landing Road - Linthicum, MD 21090
Price:
Price: $1,295.00 (Seminar Fee for One Delegate)
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Until March 10, Early Bird Price: $1,295.00 From March 11 to April 02, Regular Price: $1,495.00
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