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45 - PHR - Pharmaceutical Sciences

PHR 102 - Dissolution Testing: Importance and Principles

Code	Start Date	Duration	Venue
PHR 102	14 October 2024	5 Days	Istanbul	Registration Form Link
PHR 102	18 November 2024	5 Days	Istanbul	Registration Form Link
PHR 102	23 December 2024	5 Days	Istanbul	Registration Form Link

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Course Description

Dissolution testing poses a major challenge to the pharmaceutical, biotech and generics industries both in terms of method development and regulatory compliance.

This course is devised to cover the benefits, importance and role of dissolution testing in drug development today. Intricacies of dissolution testing with an emphasis on common problems and methods for enhancing dissolution and bioavailability of compounds will be covered. Using practical examples and case studies throughout the program, delegates will gain a thorough understanding of setting and establishing specifications for optimum dissolution testing.

Course Objectives

Identifying the factors affecting dissolution
Understanding the relationship between dissolution testing and drug adsorption
Designing optimum method development strategies
Conducting Product performance tests and Quality Control
Selecting optimum test conditions and method development
Ensuring test methods are properly validated
Clarifying global regulatory requirements
Assessing new scientific developments and trends

Who Should Attend?

This course is designed for professionals working in the following areas:

Regulatory Affairs
Pharmaceutical Development
Analytical Development
Project Management
Quality Control and Assurance
Anyone who is involved in dissolution test

Course Details/Schedule

Day 1

Overview
The need for dissolution testing
Historical perspective
Theories of dissolution
Intrinsic dissolution
ISO standards

Day 2

Drug adsorption dynamics
An overview of drug adsorption and how it relates to dissolution testing
Effects of gastric motility and pH on the drug adsorption process
Sink conditions-a regulatory requirement or a physiological fact?
Pharmacopial status of dissolution testing

Day 3

Regulatory aspects of dissolution testing
Official guidance of the FDA and the EMEA
The role of dissolution in the regulatory submission
The role of dissolution in the regulatory process
Quality control aspects of dissolution testing
Level 1,2 and 3 testing; what is it and what does it mean?
OODS-Out of Dissolution Specification

Day 4

Setting specifications
The regulatory view
The formulation development view
Stability issues
Development of Dissolution Tests
Simple formulations
Modified release formulations
Test requirements for hydroalcohol media to control burst effects
Poorly soluble drugs
Combination products
Dissolution For Non-Conventional Dosage Forms
Performance Verification Testing

Day 5

Validation of dissolution tests
Equipment qualification
Chemical and mechanical calibration
Dissolution testing validation requirements
Automation
Analytical procedures
Dissolution and Bioavailabity/Bioequivalence
Dissolution testing as a surrogate marker
Biomimetic methods
In vivo/in vitro correlations

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SAHARA Group Training and Consultancy INC (in Turkish: SAHARA Group Eğitim ve Danışmanlık AŞ)

Tax Office: Beyoğlu (Istanbul/Turkiye,Tax No: 7390525151 (Vergi Dairesi: Beyoğlu (İstanbul), Vergi No: 7390525151)

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45 - PHR - Pharmaceutical Sciences

PHR 102 - Dissolution Testing: Importance and Principles

Course Description

Course Objectives

Who Should Attend?

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