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DITEBA is a global leader in complex analytical and bioanalytical testing, providing solutions and services to the pharmaceutical, biopharmaceutical and nutraceutical industries.

We support both large and small molecule testing for various dosage forms including solids, semi-solids, liquids, aerosols and other special dosage forms. Our work is focused in several core areas including: In Vitro Release Rate Testing (IVRT) services; stability storage and testing; method development and validation and QC testing at our fully accredited facility.

OUR VISION

To be the contract partner of choice for analytical and bioanalytical services.

OUR COMMITMENT TO OUR CUSTOMERS

Diteba will deliver great science and quality excellence, on time, every time.

OUR EXPERTISE

Our science team has extensive knowledge, experience and expertise in analytical and bioanalytical analysis specializing in the ability to resolve the most challenging method development difficulties facing our customers for both large and small molecules.

OUR ACCREDITATIONS

Diteba’s testing services comply with both GLP and GMP and are performed in accordance with the requirements of the US 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. Diteba is also licensed by Health Canada to handle controlled drugs and substances.

WHAT DO OUR CUSTOMERS THINK?

We are very pleased we contracted Diteba for a wide range of GMP/GLP analytical work for both biomolecules and small molecules in various dosage forms and drug development stages, including Phase 1 to Phase 3 products. The work included method development, validation, drug product release and stability programs. Their staff was supportive, well-informed and experienced with the most up-to-date scientific methods, quality practices and regulatory requirements.”
- Theresa Horne, MSc. – Director, Analytical

We recently engaged Diteba to undertake an IVRT study for a topical spray formulation using the finite dose technique and static Franz Diffusion Cells. Not only did they resolve some very difficult technical obstacles, but they completed the project to our complete satisfaction. I am pleased we chose them to be our IVRT partner.”
- Dr. Chalil Abu-Gnim, Senior Director, Analytical R&D

We had a very positive experience working with Diteba on our Phase 2 oligonucleotide based drug product. The GMP work conducted with Diteba was used to support orphan drug, US and European pre-clinical toxicology, pharmacology, Phase 1 and Phase 2 clinical work as part of an FDA authorized IND and EMA authorized CTAs. That work included analytical methods development, validation, accelerated and long term stability which is still ongoing. We would definitely choose to work with Diteba again on future projects.”
- Dayton T. Reardan, Ph.D., RAC - Vice President of Regulatory Affairs

referrals

We had a very positive experience working with Diteba on our Phase 2 oligonucleotide based drug product. The GMP work conducted with Diteba was used to support orphan drug, US and European pre-clinical toxicology, pharmacology, Phase 1 and Phase 2 clinical work as part of an FDA authorized IND and EMA authorized CTAs. That work included analytical methods development, validation, accelerated and long term stability which is still ongoing. We would definitely choose to work with Diteba again on future projects.
Dayton

6/19/2014

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Vendor Showcase

Diteba, Leaders in IVRT and IVPT Analytical Services

Diteba, Leaders in IVRT and IVPT Analytical Services

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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