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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:

• 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

Who will Benefit:

• Laboratory staff responsible for developing dissolution methods
• Personnel responsible for equipment qualification
• Quality control analysts
• Regulatory affairs professionals
• Quality management

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

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 close

SPEAKER

Mark 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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