Many drug products applied to the skin do not have well established procedures and/or acceptance criteria for their major critical quality attributes (e.g. uniformity of containers and uniformity of dose in metered containers for semisolid dosage forms and cold flow for transdermal systems).
This workshop will provide a forum for the discussion of drug products applied to the skin, including ointments, gels, creams, lotions, solutions, suspensions, foams and passive transdermal systems.
The use of in vitro drug release testing for both semisolid drug products and transdermal systems will also be discussed.
Agenda Call for Poster Abstracts
Topics
Day One: Transdermal Systems
- Development and manufacture of Transdermal Systems (TDS)
- Quality by Design (QbD) for TDS
- Particularities of TDS analytics
- Cold flow
- Shear test
- In vitro drug release testing
- Harmonization
Day Two: Semisolid Dosage Forms
- Development and manufacture of semisolid products
- QbD for semisolid products
- Rheological properties of products applied to the skin
- Uniformity in containers
- Packaging with dosing
- Predictive power of in vitro drug release
- Challenges in developing drug release methodologies for topically applied formulations
- Topical drug delivery: US regulatory perspectives on biopharmaceutics and clinical pharmacology
- Developing regulatory standards for characterizing critical quality attributes and performance attributes for topical semisolid dosage forms
Objectives
- Discuss the challenges associated with developing and manufacturing drug products applied to the skin.
- Provide information on how to identify and monitor critical quality attributes.
- Collect input from the audience on the challenges and alternatives for quality testing of products applied to the skin.
- Have an open discussion on items currently not well defined and on differences in international regulations.
Who Should Participate
- Analytical chemists
- QA/QC analysts
- R&D scientists, managers
- Manufacturing scientists, managers
- Regulatory affairs specialists
- Contract research organizations
- Contract manufacturing organizations
Participant Resources
- <3> Topical and Transdermal Drug Products – Product Quality Tests
- <724> Drug Release
- <1724> Semisolid Drug Products – Performance Tests
- <771> Ophthalmic Products – Quality Tests
Registration Information
Regular Price Information
Online registration will be available through Monday, September 14. After that date, registration will be available on-site at the workshop.
|
Participant Type |
Regular Fee Per Person (1-2 individuals from the same organization) |
Discounted Fee Per Person – 10% off (3 or more individuals from the same organization; all must register at the same time to receive the discounted fee) |
|
Industry |
$975 |
$875 |
|
Association/Academia |
$775 |
$695 |
|
Government |
$175 |
Not available |
|
Student(Full-time; valid I.D. required) |
$175 |
Not available |
Location
USP–U.S. Meetings Center
12601 Twinbrook Parkway
Rockville, MD 20852
United States
Phone: +1-301-816-8130
See map: Google Maps