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.
For a number of reasons, from issues with oral dosage first-pass metabolism of the liver, the acidic environment of the gastrointestinal tract, and problems of absorption in the stomach, to an aging population who have a hard time swallowing pills orally (pediatric patients also fall into this category), the clinical need for alternatives to oral solid dosage delivery has never been greater.
A wide range of topical and transdermal products is expected to reach the U.S. market in the near future to address these issues. The U.S. market for drug delivery technologies is expected to increase from $20 billion to more than $50 billion. This increase in the number of topical and transdermal drugs being commercialized for sale in the United Sates, combined with an increasing emphasis on IVRT by the FDA for new submissions, SUPAC and other regulatory requirements, has significantly increased the need for CROs who can provide quality IVRT and IVPT services in a timely manner to meet this new demand.
The FDA is placing more and more emphasis on IVRT as an essential quality tool for topical and transdermal products. According to the FDA, there are many added value reasons to use IVRT for Quality Control. In the absence of Quality by Design (QbD) assurance, IVRT can be sensitive to changes in Q3 quality attributes, and can provide performance verification to help mitigate risks associated with potential failure modes. Also, IVRT does not have to be perfect, or provide In Vitro-In Vivo Correlation (IVIVC), to be highly valuable for quality risk management.
Diteba, a global leader in In Vitro Release Rate and In Vitro Permeation (IVPT) analytical method development, validation and testing services, has continued to remain current with both market and regulatory environments. On the market side, they have more than doubled their IVRT/IVPT capacity in the last twelve months to meet the fast-growing demand for these types of topical and transdermal drug analytical services. On the regulatory side, they remain at the scientific and leadership forefront in order to meet or exceed the most up-to-date regulatory requirements. Diteba recently passed two FDA inspections, the second inspection taking place September 2015, with no notice and a focus on Diteba’s IVRT Quality program, SOPs and project history.
Some of the IVRT/IVPT services Diteba performs include:
- In-process testing for formulation optimization.
- Quality control, lot to lot variability.
- Skin penetration, depth profiling and absorption studies for BE/BA evaluation.
- Full compliance method development and validation with SUPAC-SS and FDA requirements.
- In Vitro release comparison testing for pre and post-changes formulations.
- In Vitro-In Vivo (IVIVC) Correlation.
- In Vitro Skin Absorption Studies, Test Method OECD 428 and new EMA guidelines.
- Data interpretation and FDA submission for approval of SUPAC-related changes.
Diteba's testing services are performed in accordance with the requirements of the U.S. Food and Drug Administration (FDA), Health Canada and the International Conference on Harmonization (ICH). Diteba is licensed by Health Canada as a GMP drug establishment and registered as a drug establishment with the FDA.
To Learn More:
Visit Diteba at AAPS Booth #1268, November 13th to 17th, 2016
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