Comprehensive Approach to Dissolution Testing & Method development

About Course

Provides a practical guide to designing, evaluating, and troubleshooting dissolution methods, setting acceptance criteria, interpreting dissolution data and profiles with statistical tools, and applying BCS-based biowaivers through real-world case studies in line with global standards.

By the end of this course, you will be able to: Understand the significance of dissolution testing and the key factors affecting its performance
Develop discriminative dissolution methods based on the international guidelines with case studies
Analyze and troubleshoot typical issues in dissolution testing & solutions
Set specifications & Acceptance Criteria for dissolution methods with case studies
Interpret dissolution data & compare profile curves using statistical tools in real-world cases
Apply global regulatory guidelines for BCS-based biowaivers

Course Content

Module 1 : Fundamentals of Dissolution Testing and Its Strategic Design in Drug Development

Lesson 1 – Dissolution principles: Significance, mechanisms, and in-vivo relevance

00:00
Lesson 2 – Factors affecting dissolution performance & product stability with case studies

00:00
Lesson 3 – Applicability of Dissolution Testing

00:00
Lesson 4 – Alternative methods to dissolution testing according to Regulatory Guidelines

00:00
Lesson 5 – Selection of dissolution method parameters based on Schematic Guide to Dissolution Method Design with Case studies

00:00

Module 2 : Dissolution Method Development & Troubleshooting in Practice

Module 3 : Dissolution Data Analysis, Profile Comparison & Biowaiver Principles

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Comprehensive Approach to Dissolution Testing & Method development

About Course

What Will You Learn?

Course Content

Module 1 : Fundamentals of Dissolution Testing and Its Strategic Design in Drug Development

Lesson 1 – Dissolution principles: Significance, mechanisms, and in-vivo relevance

Lesson 2 – Factors affecting dissolution performance & product stability with case studies

Lesson 3 – Applicability of Dissolution Testing

Lesson 4 – Alternative methods to dissolution testing according to Regulatory Guidelines

Lesson 5 – Selection of dissolution method parameters based on Schematic Guide to Dissolution Method Design with Case studies

Module 2 : Dissolution Method Development & Troubleshooting in Practice

Lesson 1 – Critical design considerations in dissolution methods with Case studies

Lesson 2 – Step-by-Step Dissolution Method Development Process

Lesson 3 – Specific Recommended dissolution media for challenging Dosage forms

Lesson 4 – Common Bad habits in Dissolution & how to avoid

Lesson 5 – Troubleshooting: Typical dissolution Issues and solutions

Lesson 6 – Interpretation of dissolution results through case-based learning and USP tolerance criteria.

Lesson 7 :

Module 3 : Dissolution Data Analysis, Profile Comparison & Biowaiver Principles

Lesson 1 – Understand Q-value, USP stages & set dissolution acceptance Criteria with case studies

Lesson 2 –Compare Dissolution curves & Profiling: Why, how & when

Lesson 3 – Interpret profiles Using Statistical Tools: Similarity Factor Calculation with Case studies

Lesson 4 – Understand BCS-based Biowaivers: regulatory requirements with real-world cases

Lesson 5 – Compiling key dissolution testing references, databases and regulatory guidelines

Earn a certificate

About Course

What Will You Learn?

Course Content

Module 1 : Fundamentals of Dissolution Testing and Its Strategic Design in Drug Development

Lesson 1 – Dissolution principles: Significance, mechanisms, and in-vivo relevance

Lesson 2 – Factors affecting dissolution performance & product stability with case studies

Lesson 3 – Applicability of Dissolution Testing

Lesson 4 – Alternative methods to dissolution testing according to Regulatory Guidelines

Lesson 5 – Selection of dissolution method parameters based on Schematic Guide to Dissolution Method Design with Case studies

Module 2 : Dissolution Method Development & Troubleshooting in Practice

Lesson 1 – Critical design considerations in dissolution methods with Case studies

Lesson 2 – Step-by-Step Dissolution Method Development Process

Lesson 3 – Specific Recommended dissolution media for challenging Dosage forms

Lesson 4 – Common Bad habits in Dissolution & how to avoid

Lesson 5 – Troubleshooting: Typical dissolution Issues and solutions

Lesson 6 – Interpretation of dissolution results through case-based learning and USP tolerance criteria.

Lesson 7 :

Module 3 : Dissolution Data Analysis, Profile Comparison & Biowaiver Principles

Lesson 1 – Understand Q-value, USP stages & set dissolution acceptance Criteria with case studies

Lesson 2 –Compare Dissolution curves & Profiling: Why, how & when

Lesson 3 – Interpret profiles Using Statistical Tools: Similarity Factor Calculation with Case studies

Lesson 4 – Understand BCS-based Biowaivers: regulatory requirements with real-world cases

Lesson 5 – Compiling key dissolution testing references, databases and regulatory guidelines

Earn a certificate

Student Ratings & Reviews

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