Comprehensive Approach to Dissolution Testing & Method development
About Course
Course Language: English
A comprehensive and practical guide to designing, evaluating, and troubleshooting dissolution methods for pharmaceutical dosage forms.
This course covers the significance of dissolution testing and the key factors influencing its performance; the full development of discriminative dissolution methods in alignment with international regulatory guidelines; resolving common issues in dissolution testing; setting specifications and acceptance criteria for different release systems; interpreting dissolution data and profile comparisons using statistical tools; applying BCS-based biowaivers through real-world case studies; and providing a comprehensive reference toolkit of key regulatory documents, scientific databases, and analytical tools.
Applied knowledge is reinforced through assessments and case-based learning, equipping participants to design, evaluate, and justify dissolution methods that meet global scientific and regulatory expectations.
Course Content
Module 1 : Fundamentals of Dissolution Testing and Its Strategic Design in Drug Development
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Lesson 1 – Dissolution principles: Significance, mechanisms, and in-vivo relevance
04:13 -
Lesson 2 – Factors affecting dissolution performance & product stability with case studies
04:25 -
Lesson 3 – Applicability of Dissolution Testing
02:30 -
Lesson 4 – Alternative methods to dissolution testing according to Regulatory Guidelines
02:58 -
Lesson 5 – Selection of dissolution method parameters based on Schematic Guide to Dissolution Method Design with Case studies
09:43 -
Module 1 Quiz
Module 2 : Dissolution Method Development & Troubleshooting in Practice
Module 3 : Dissolution Data Analysis, Profile Comparison & Biowaiver Principles
Comprehensive Approach to Dissolution Testing & Method development
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