Pharmaceutical Dissolution Testing (com) A

Singapore

*** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! ***
REGISTER TODAY! 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
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar
 Learning Objectives:
<ul><li>Reasons for dissolution testing
</li><li>Factors affecting drug solubility and dissolution rate
</li><li>Apparatus for the dissolution/release testing of different dosage forms
</li><li>Instrument qualification approaches
</li><li>Dissolution tests for immediate-release and modified-release drug products
</li><li>Release testing of transdermal products
</li><li>Accelerated dissolution testing of novel dosage forms (e.g. implants, polymeric microspheres etc.)
</li><li>Calculation and interpretation of test results
</li><li>Dissolution method development
</li><li>Options for the analytical finish
</li><li>Dissolution method validation
</li><li>Troubleshooting anomalous data
</li><li>The role of dissolution testing in establishing bioequivalence (biowaivers)
</li><li>In vitro-in vivo correlation
</li></ul>Who will Benefit:
<ul><li>Laboratory staff responsible for developing dissolution methods
</li><li>Personnel responsible for equipment qualification
</li><li>Quality control analysts
</li><li>Regulatory affairs professionals
</li><li>Quality management</li></ul>AGENDADAY 01(8:30 AM - 4:30 PM)
08:30 AM – 09:00 AM – Registration Process, Meet &amp; Greet
9:00 AM -10:30 AM
Reasons for dissolution testing
Safety
Efficacy
Dissolution testing in the context of other quality parameters
Dissolution theory
Factors affecting solubility
10:30 AM -10:45 AM Break
10:45 AM -12:00 Noon
Dissolution theory (continued)
Dissolution rate
Dissolution medium
Intrinsic and apparent dissolution
12:00 Noon -1:00 PM Lunch
1:00 PM -3:00 PM
Dissolution apparatus
Regulatory references
Apparatus for solid oral dosage forms (USP apparatus 1, 2 3 and 4)
Non-compendial options (e.g. small-volume apparatus and peak vessels)
Apparatus for transdermal dosage forms (USP apparatus 5, 6 and 7)
3:00 PM -3:15 PM Break
3:15 PM - 4:30 PM
Dissolution apparatus (continued)
Apparatus for topical semi-solid dosage forms (vertical diffusion cell)
Intrinsic dissolution testing
Ph. Eur. apparatus for medicated chewing gum
Requirements for different release types
Immediate release
Delayed release
Extended release
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
Transdermal patches
Topical semi-solids
Dissolution testing for novel dosage forms
Experimental options
Accelerated release testing
10:30 AM -10:45 AM Break
10:45 AM -12:00 Noon
Interpretation of results
Meaning of Q
Results calculation
Immediate release
Delayed release
Extended release
12:00 Noon-1:00 PM Lunch
1:00 PM-3:00 PM
Equipment qualification
Regulatory/industry body guidance
USP approach (PV tablets)
US FDA approach (enhanced mechanical qualification)
Equipment factors influencing result variability
3:00 PM -3:15 PM Break
3:15 PM - 4:30 PM
Dissolution test troubleshooting
Troubleshooting approach
Records and observations that aid 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
pH range
Volume
Surfactants
Biorelevant media
10:30 AM-10:45 AM Break
10:45 AM -12:00 Noon
Method development (continued)
Apparatus
Agitation rate
Sampling points
Assay
Acceptance criteria
12:00 Noon-1:00 PM Lunch
1:00 PM -3:00 PM
Method validation
Regulatory guidance
Experimental approaches to method validation
Justifying acceptance criteria
System suitability tests
3:00 PM -3:15 PM Break
3:15 PM - 4:15 PM
In vitro approaches to bioequivalence
Regulatory guidance (including ICH M9)
Solubility and permeability
Measuring permeability in vitro – Caco-2 and PAMPA models
Oral bioavailability and first-pass metabolism
Limitations for in vitro bioequivalence
In vitro-in vivo correlation (IVIVC)
IVIVC classes
Experimental methods for establishing IVIVCs
Regulatory uses of IVIVCs
4:15PM-4:30 PM Final questions, feedback and closeSPEAKERMark Powell
Director, Mark Powell Scientific Limited
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.

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