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.

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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.

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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.

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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.

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Essential analytical testing resources for R&D managers

Posted July 26, 2016

Top resources to help you navigate the complexities of pharmaceutical testing

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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.

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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.

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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

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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.

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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?

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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.

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