Since 2002, Affygility Solutions has been providing high-quality permitted daily exposure (PDE)¹ reports (a.k.a. monographs) for active pharmaceutical ingredients (APIs). These reports have been sold to over 800 clients in nearly 70 countries. These reports are authored by Diplomate American Board of Toxicology (DABT) and European Registered Toxicologists (ERT) as recommended by the following regulatory authorities:

• European Medicines Agency (EMA);
• Pharmaceutical Inspection Co-operation Scheme (PIC/s);
• National Health Surveillance Agency or Agência Nacional de Vigilância Sanitária (ANVISA); and
• World Health Organization (WHO).

In April 2012, Affygility Solutions was the first company in the world to offer the online, instant download of OEL and PDE reports. Today, OEL Fastrac is a CPhI and 2021 HPAPI Summit award-winning catalog with over 2,500 PDE reports. Customers have rated our PDE reports and support at a Net Promoter Score of 100!

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Why Affygility Solutions for all your PDE report needs?

OEL Fastrac ADE / PDE reports offer the following benefits:

• Save money and time with instant download of reports available 24/7
• Ensure compliance with EMA, PIC/s, ANVISA, and WHO requirements with FREE periodic updates that are automatically distributed
• Achieve cost-effective risk-management and numbers you can trust with CPhI award winning PDE reports that are prepared by experienced/certified (ERT and DABT) toxicologists with real pharmaceutical industry experience
• Save money and demonstrate compliance to auditor questions through FREE online/offline technical support

What is a PDE?

As defined by the EMA’s Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities, “The PDE represents a substance-specific dose that is unlikely to cause an adverse effect if an individual is exposed at or below this dose every day for a lifetime.”

The PDE is then used in performing your facility’s risk assessment, according to ICH Q9, and used in the maximum allowable carryover (MACO) equation.

What can you expect in Affygility Solutions’ OEL Fastrac PDE reports?

Each PDE report contains the following information:

• Chemical and Physical Characteristics
• Therapeutic Indication
• Mechanism of action
• Efficacy and Dose
• Safety Information
• Pharmacodynamics and Pharmacokinetics
• Toxicology Summary
• Carcinogenic, Reproductive and Developmental Hazards
• Selection of the Point of Departure (PoD)
• OEL Calculations
• Control Band Assignment
• Industrial Hygiene Sampling and Analytical Methods
• ADE (PDE) Calculations
• • Choice of Adjustment and Modifying Factors
• Reference Citations

Don’t get fooled by cheap providers of PDE reports

At Affygility Solutions we see hundreds of different PDE reports each year. Often, when reviewing reports from cheap providers, we see many technical errors and tactics to fool you into thinking that you’re getting quality reports. These technical errors and tactics include:

• Relying too heavily on animal data for the selection of the point of departure (PoD) and ignoring currently available human clinical data.
• Performing a limited search strategy or not acquiring important primary sources of information.
• Ignoring conflicting data.
• Creating a different monograph for each salt form of the molecule; thus, requiring you to buy separate monographs.
• Making statements that are not scientifically supported.
• Relying on data from safety data sheets (SDS) of questionable credibility.
• Attempting to disguise a PDE report as a comprehensive document by including a report cover, a table of contents, a glossary, redundant filler material, lengthy tables, and CVs in every report. In addition, some providers use large header and footer margins with logos and addresses to make a longer document. These items provide no value and are there to just give the false impression that it’s a lengthy and comprehensive report.
• Not openly disclosing that their reports expire in 3-5 years; thus, requiring that you purchase a new report upon expiration.

Don’t settle for poor quality and cookie cutter PDE reports

Other toxicology providers sell cookie cutter monographs that are prepared by inexperienced and uncertified teams. In contrast, Affygility Solutions follows a quality-focused process when preparing PDE reports to ensure we deliver comprehensive and compliant monographs. With an increasing number of complex regulations in the pharmaceutical industry, Affygility Solutions’ experienced team of toxicologists routinely reviews new regulatory requirements and guidance to determine regulatory impacts. You can always count on Affygility Solutions to be at the forefront of developing regulatory requirements and trends. Inappropriately using the EuroTox logo on PDE reports to mislead clients into believing that the EuroTox organization certifies their reports (EuroTox is a professional society and does not certify reports or companies).

Customers can be certain they’re receiving thorough and complete reports because Affygility Solutions has a 34-step quality assurance process to validate accuracy of all monographs. Affygility Solutions also uses proprietary software tools to alert us when new safety information becomes available that might impact the OEL or PDE calculations.

Affygility Solutions has a long history of providing and supporting toxicology services. This proven track record gives customers peace of mind they’re receiving quality monographs backed with exceptional support.

Affygility Solutions understands PDE reports for natural health products

Affygility Solutions also prepares PDE reports for natural health products to address the growing nutraceutical and herbal medicinal markets. As the natural health product industry continues its upward trajectory, the need for increased toxicology expertise and resources is also rising. With Affygility Solutions’ knowledge of the complex regulations in the pharmaceutical industry, we are able to help our customers understand the unique toxicology requirements in the natural health product market. Natural doesn’t always equal safe.

Order online or request a quote for your PDE reports today!

To order online by credit card simply go to our OEL Fastrac online catalog. To request a quote for your PDE reports, simply go to our contact us form.

About Affygility Solutions

Affygility Solutions has been providing occupational health, safety, and toxicology services since 2002. Affygility serves biotechnology, pharmaceutical and medical device companies throughout the world. We provide health-based exposure limit (HBEL) monographs, occupational exposure limits and acceptable daily exposure limits for active pharmaceutical ingredients available for instant download through OEL Fastrac. Our other services include the Affytrac EHS management tool, potent compound safety and categorization, and genotoxic impurity evaluations. Affygility’s international team is located in the United States, Canada, Brazil, and the United Arab Emirates.

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1. The EMA, PIC/s, ANVISA, and WHO consider the terms PDE and ADE to be effectively synonymous.