Pharmaceutical Dissolution Testing (Singapore – April 1-3, 2020) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Pharmaceutical Dissolution Testing” conference has been added to ResearchAndMarkets.com’s offering.

Pharmaceutical dissolution testing helps to ensure the safety and efficacy of a variety of different formulated drug products. This three-day course covers the theory behind drug solubility and dissolution rate, regulatory expectations, experimental technique, interpretation of test results, investigating anomalous data, setting suitable dissolution specifications and the development and validation of dissolution tests. It also includes details of the USP and US FDA approaches for equipment qualification as well as the use of in vitro dissolution testing to establish bioequivalence. The establishment and uses of in vitro-in vivo correlations (IVIVC) will also be discussed.

The focus of the course will be on solid oral dosage forms, but apparatus and techniques for other types of drug product will also be presented, including transdermal drugs and dosage forms designed for release over a period of weeks or months. The course consists of lectures and exercises/workshops designed to reinforce the taught component.

By the end of the course, you will understand the science underpinning dissolution/drug release testing, and have the knowledge required to:

• Avoid practical errors in the dissolution/release testing of drug products
• Select appropriate test conditions (dissolution medium, apparatus, agitation rate, time points)
• Validate dissolution methods in accordance with regulatory expectations
• Reduce dissolution result variability
• Troubleshoot anomalous results
• Set scientifically-sound acceptance criteria
• Implement a compliant dissolution equipment qualification strategy
• Use in vitro data to establish bioequivalence
• Understand the potential for establishing an in vitro-in vivo correlation (IVIVC) and the regulatory application of different IVIVC classes

Learning Objectives:

• Reasons for dissolution testing
• Factors affecting drug solubility and dissolution rate
• Apparatus for the dissolution/release testing of different dosage forms
• Instrument qualification approaches
• Dissolution tests for immediate-release and modified-release drug products
• Release testing of transdermal products
• Accelerated dissolution testing of novel dosage forms (e.g. implants, polymeric microspheres etc.)
• Calculation and interpretation of test results
• Dissolution method development
• Options for the analytical finish
• Dissolution method validation
• Troubleshooting anomalous data
• The role of dissolution testing in establishing bioequivalence (biowaivers)
• In vitro-in vivo correlation

Agenda:

Day 01 (8:30 AM – 4:30 PM)

08:30 AM – 09:00 AM – Registration Process, Meet & Greet

9:00 AM -10:30 AM

• Reasons for dissolution testing
• Dissolution testing in the context of other quality parameters
• Dissolution theory

10:30 AM -10:45 AM Break

10:45 AM -12:00 Noon

• Dissolution theory (continued)

12:00 Noon -1:00 PM Lunch

1:00 PM -3:00 PM

• Dissolution apparatus

3:00 PM -3:15 PM Break

3:15 PM – 4:30 PM

• Dissolution apparatus (continued)
• Requirements for different release types

Day 02 (8:30 AM – 4:30 PM)

8:30 AM-8:59 AM Attendees arrive

9:00 AM -10:30 AM

• Requirements for non-oral dosage forms

10:30 AM -10:45 AM Break

10:45 AM -12:00 Noon

• Interpretation of results

12:00 Noon-1:00 PM Lunch

1:00 PM-3:00 PM

• Equipment qualification

3:00 PM -3:15 PM Break

3:15 PM – 4:30 PM

• Dissolution test troubleshooting

Day 03 (8:30 AM – 4:30 PM)

8:30 AM – 8:59 AM Attendees arrive

9:00 AM – 10:30 AM Method development

• Choice of dissolution medium

10:30 AM-10:45 AM Break

10:45 AM -12:00 Noon

• Method development (continued)

12:00 Noon-1:00 PM Lunch

1:00 PM -3:00 PM

• Method validation

3:00 PM -3:15 PM Break

3:15 PM – 4:15 PM

• In vitro approaches to bioequivalence
• In vitro-in vivo correlation (IVIVC)

4:15 PM – 4:30 PM Final questions, feedback, and close

Speakers:

Mark Powell

Fellow

Royal Society of Chemistry

Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.

For more information about this conference visit https://www.researchandmarkets.com/r/wptj9g

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