Understanding Concepts and Regulatory Compliance Requirements for in Vitro-in Vivo Correlations (IVIVC) and Predicting Plasma Drug Levels (NTZ)
At
The DoubleTree Baltimore-BWI Airport
For more information: https://www.eventbrite.com/e/understanding-concepts-and-regulatory-compliance-requirements-for-in-vitro-in-vivo-correlations-tickets-43441651148?aff=RMV
DESCRIPTION
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Understanding Concepts and Regulatory Compliance Requirements for in Vitro-in Vivo Correlations (IVIVC) and Predicting Plasma Drug Levels
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.
Why should you attend:
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This seminar will focus on:
Highlighting the current misunderstandings of the concepts which lead to disappointments in successful application of IVIVC in particular from regulatory compliance perspective.
In vitro and in vivo associations which have often been mistakenly presented as IVIVC resulted in lack of anticipated success of IVIVC and its applications.
The use of non-validated testers and experimental conditions for in vitro product characterization.
Addressing the above mentioned shorting comings by suggesting scientifically valid yet simple solutions.
Areas Covered in the Session:
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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:
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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
AGENDA
Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If your company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
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For more information: https://www.eventbrite.com/e/understanding-concepts-and-regulatory-compliance-requirements-for-in-vitro-in-vivo-correlations-tickets-43441651148?aff=RMV
Eventbrite: https://www.eventbrite.com/o/event-promotions-by-new-york-events-list-11118815675
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