Formulating Generic Drug Substances: Overview of FDA Public Meeting
Posted January 22, 2018
Recently, the Food and Drug Administration (FDA) organized two very interactive public workshops. The first, Demonstrating Equivalence of Generic Complex Drug Substances and Formulation (October 5, 2017) will be outlined here.
Assessing Bioequivalence in Generic Topical Dermatological Products: There Are Alternatives
Posted March 30, 2017
By using in vitro release testing with skin permeation testing, acyclovir product developers can obtain biowaiver status in lieu of clinical trials following new FDA guidance, a change that potentially could save sponsors millions of dollars in product development.
Connect with DiTEBA's IVRT/IVPT experts at AAPS 2016
Posted October 25, 2016
Join DiTEBA at AAPS (November 13-17), booth 1268, to meet with our team and learn how DiTEBA can assist you with your analytical method development, validation and testing needs.
Challenges of developing in vitro release methods for petrolatum-based ointment formulations
Posted September 1, 2016
Ointments are therapeutically effective and, therefore, there are large varieties of these topical products currently available in the North American market. Consequently, there is high demand for developing a reproducible and sensitive IVRT methodology that can be used for product performance, quality control or SUPAC-specified changes.
Essential analytical testing resources for R&D managers
Posted July 26, 2016
Top resources to help you navigate the complexities of pharmaceutical testing
Regulatory challenges and bioassay discussions at WRIB
Posted July 6, 2016
Hear from Dr. Theo Kapanadze about WRIB, which provided the bioanalytical community with key information on bioanalysis of large and small molecules to achieve scientific excellence, improve quality and deliver better regulatory compliance.
Biowaivers for topical drug products: Regulatory approaches, criteria and requirements
Posted June 20, 2016
In order to meet regulatory requirements, an in vitro release methodology should be appropriately developed and validated. Learn how having an appropriate validated IVRT method is mandatory for semisolid product development and FDA approval.
New E-Book on IVRT and IVPT for topical and transdermal drugs
Posted May 24, 2016
Everything you need to know about In Vitro Release Testing (IVRT) and In Vitro Permeation Testing (IVPT) for topical drugs
Updates for Quality and Performance Testing of Mucosal Drug Products: USP Viewpoint
Posted May 5, 2016
New USP testing procedures and recommendations for non-standardized procedures for the testing of mucosal drug products were discussed. Below is a summary of some key points covered at the USP Network conference which you should be aware of before testing a mucosal drug.
Join us at the Innovation Networking Summit, April 6th and 7th
Posted March 23, 2016
Meet with our analytical/bioanalytical team to discuss the FDA's emphasis on IVRT (in vitro release testing) for topical/transdermal drug submissions?
CROs are increasing their IVRT capacity as FDA emphasizes its use for topical/transdermal drug submissions
Posted October 13, 2015
A Burgeoning Demand for In Vitro Release Rate (IVRT) Services Related to FDA Submissions for the Commercialization of Topical and Transdermal Drug Products in the United States has Caused Many CROs to Significantly Increase Their IVRT Analytical Services Capacity to Keep Up.