Biorelevant Dissolution Testing
- Real Time Online Delivery – Live Training Sessions
- Virtual Attendance for 5 Days Training
- Guided Learning Hours – 20
- Case Studies, Practical Exercises, Q & A,
- Pre-Course Access: Intro Session Coupon, Pre-Event Questionnaire, Presentation Slide Deck
Course Overview
Dissolution testing can play an important role in several areas for drug products as a quality control tool to monitor batch-to-batch consistency of drug release from a dosage form and as an in vitro surrogate for in vivo performance that can guide formulation development and ascertain the need for bioequivalence (BE) testing. The possibility of substituting dissolution tests for clinical studies has been revealed by the development of the Biopharmaceutics Classification System (BCS), and dissolution tests that can predict the in vivo performance of drug products could serve this purpose.
This 5 Day Online Course will highlight the uses of dissolution/release testing as a tool during the drug development and routine quality control, and will focus on some of the main considerations for dissolution test development, especially in an era where the majority of drugs in development are poorly soluble.
These Daily 4 Hrs sessions will discuss some of the most useful practices and procedures that might contribute to better planning, designing, and development of different types of dosage form based on dissolution testing, leading to a successful regulatory submission and approval within the planned costs and time.
Trainer’s Profile
Our Expert Trainer is a Fellow of Royal Society of Chemistry (RSC) with over 30+ years of experience as an analytical chemist. An expert in sampling and sample preparation, chromatography, spectroscopy & pharmaceutical dissolution testing!
A Phd degree in analytical chemistry, our expert worked at a senior level in a number of industrial laboratories with responsibility for the development of analytical methods.
Our Expert has provided numerous Public & In-House Lectures, Workshops, and Seminars in recent past.
Key Takeaways
- Regulatory acceptability of dissolution conditions
- Correlation with in vivo performance
- Dissolution theory
- Requirements for different dosage forms/release profiles
- Equipment Qualification
- Successful method development strategies
- Investigating anomalous results
- Release testing for novel dosage forms
- Biorelevant media
Who Should Attend
- Analytical Development Scientists
- Quality Control Scientists
- Formulation Development Scientists
- Regulatory Affairs (RA) Delegates
- QA / QC Managers
- Chemistry Manufacturing and Controls (CMC) representatives
- Project Managers
- Qualified Persons
- Any executives that would like to expand their knowledge in biorelevant dissolution testing
For participation details contact
Mithun Siddartha
+1 780 851 7197 (Canada)