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Department of Environmental Health

Risk Science Center (RSC)

Pharmaceutical Support

The Risk Science Center is a world leader in deriving safe dose estimates for human health.

At the Risk Science Center, pharmaceutical services build on our strength as a leader in toxicological risk assessment. Whether you need an Occupational Exposure Limit set for an active pharmaceutical ingredient, are concerned about the safety implications of an impurity in your raw material or finished product, or are not sure how a regulatory guidance applies to your particular situation, we have the expertise to meet your needs. Our highly qualified team includes occupational physicians, industrial hygienists, pharmacists, and board-certified toxicologists.


Occupational Exposure Limits (OEL) and Workplace Risk Assessment


OccupationalWe specialize in producing OELs for small and large molecules, complex biologic materials, antibodies, and other proteins. Our assessments feature state-of-the-art weight of evidence analysis for point of departure and uncertainty factor determinations. We provide sound, science-based limits that protect worker health.



  • Occupational Exposure Limits (OEL) Development
    We can help pharmaceutical companies develop defensible science-based OELs and hazard bands.  We routinely develop safe limits for pipeline and legacy active pharmaceutical ingredients (APIs). 
  • Hazard Banding (Control Banding)
    Hazard banding provides a tool for hygienists to perform risk management in the workplace when the available data are limited.  We can help you effectively manage risk by applying hazard banding to new and data-poor compounds.
  • Health and Safety Clearance of Chemicals
    We can develop customized frameworks for conducting screening level risk assessments for chemicals newly introduced to facility operations.


Product Quality Limits for Small and Large Molecules and Medical Devices


pharmaceuticalGet to know your impurities better.  Trace amounts of impurities are present in virtually all drug products.  Some of them are harmless, while others can present a risk to human health.  The Risk Science Center sets safe levels for impurities to protect human health.  We can develop processes and train your staff in human health risk assessment to help ensure product safety.


  • Impurity Acceptable Daily Exposure (ADE) Values
    The ADE concept is based on "the daily exposure to a chemical, over a predefined period which appears to be without appreciable risk on the basis of all known facts at the time."

    The Center provides health-based ADE limits for pharmaceutical impurities including starting materials, intermediates, reaction by-products, heavy metals, process reagents, leachables, degradants, and interaction products.  Using the most sensitive endpoint, we will integrate available pharmacokinetic, pharmacodynamic, and state-of-the-art dose-response modeling approaches to provide safe daily human exposure limits.  

    We can also design, monitor, and manage toxicological testing of impurities in pharmaceutical products.
  • Excipient Safety Evaluation
  • From simple to novel, we can provide safe exposure limits for excipients taking into consideration the effects of excipients on the bioavailability of the active pharmaceutical ingredient (API).

  • Cleaning Validation Limits
    The objectives of Good Manufacturing Practice (GMP) include prevention of possible contamination of a manufactured product with substances carried over from previous products.  Substances of concern include carryover of the API, excipients, residues of cleaning agents, and lubricants.  The Risk Science Center can help you:

    + Determine whether dedicated production lines are recommended for your products;

    + Set maximum allowable carryover limits for products manufactured in shared facilities.

Risk Assessment Process Development and Training

TrainingThe Risk Science Center recognizes that different occupational professionals within a company can have very different approaches to risk assessment.  Often, this is attributable to differences in the process used for deriving safe limits.  We specialize in harmonizing risk assessment processes and can help you develop internal processes that are in line with company and regulatory policies.

  • Procedural Assistance
    We can help you develop Standard Operating Procedures (SOPs), work instructions, and/or guidance documents using the best available science to support procedural steps in risk assessment.

  • Health and Safety Clearance of Chemicals 
    We can develop and implement customized frameworks for conducting screening level risk assessments for chemicals in facility operations.

  • Pharmaceutical Risk Assessment Training Courses
    We provide hands-on training in hazard characterization, dose-response modeling, and limit setting for both cancer and non-cancer effects.  We can tailor training courses to the needs of pharmaceutical risk assessors, managers and other professionals involved in setting safe exposure limits.

    We provide several risk resources and training programs through our Global Outreach Program. These programs include our popular "Dose-Response Assessment Boot Camp" which provides intensive, hands-on training in hazard characterization and dose-response assessment for human health risk assessments.  Learn more.

  • Safety Data Sheet Development
    Using a state-of-the-art weight of evidence analysis, we can author, audit, and update GHS-Compliant Safety Data Sheets (SDS) for APIs and other chemicals.  We will ensure that your documents provide the information needed to protect your workers, the environment, and achieve regulatory compliance.

Support for Nonclinical Drug Discovery and Development

TrainingOur team of toxicologists has extensive experience in drug discovery and development, and a proven track-record of managing nonclinical testing programs that have contributed to marketing authorization approvals. Our experience includes evaluations of small molecules, traditional herbal medicines, biologics, and medical devices in numerous therapeutic areas.



  • Risk Assessment Training
    Hands-on training in hazard characterization, dose-response modeling and limit setting for both cancer and non-cancer effects, tailored to the needs of pharmaceutical risk assessors. Learn more.

  • Regulatory Writing
    We can provide expertly prepared nonclinical summaries and overviews for regulatory submissions, investigator brochures, and annual regulatory updates.  TERA can also help you respond to regulatory comments and resolve science-based regulatory issues.

  • Design, Interpretation and Reporting of Pharmacology, Toxicology, and Safety Pharmacology Studies
    We can aid in designing scientifically sound nonclinical studies. We can also assist in monitoring studies placed at CROs, reviewing study reports, and providing feedback.

  • Expert Reviews
    We is a world leader in peer review.  Our expert reviews of nonclinical data packages enable you to make important regulatory and process decisions, as well as facilitating an understanding of key study strengths and weaknesses and their appropriateness for your particular use. We can also identify data gaps, inconsistencies, and the next steps for future work. Learn more.

Alliances and Partnerships

AlliancesIn solving risk problems for a diverse array of government and private sponsors, we apply a collaborative philosophy that emphasizes partnership building, allowing us to expand our pool of expertise, build on multiple perspectives, and ensure the use of the best science. These strengths form the basis for our development of independent and science-driven analyses for a range of risk assessment needs.

  • Strategic Regulatory Consulting (SRC)
    The Risk Science Center’s pharmaceutical toxicology group provides comprehensive occupational health, pharmaceutical, and medical device support from start to finish. Learn more.

  • Alliance for Risk Assessment (ARA)
    The Risk Science Center is a proud member of the Alliance for Risk Assessment, a collaborative effort of organizations dedicated to supporting public health protection by improving the process and efficiency of risk assessment. Given a limited supply of time, resources, and know-how, public health protection is an effort that requires cooperation, organization, and prioritization. The Alliance aims to help.  Learn more.

  • Fellows Program
    The Fellow Programs is a collaboration with senior scientists who provide additional depth in specialized areas of toxicology.  Fellows share the Risk Science Center's mission and values, and seek to improve risk assessment practice.  

  • Occupational Alliance for Risk Science (OARS)
    The Occupational Alliance for Risk Science (OARS) is an initiative to facilitate sharing of information with workers and occupational health and safety professionals. OARS provides a forum for information exchange about exposure guidance for chemical stressors, methods for improving occupational risk assessments, and training opportunities.  Learn More.


Pharmaceutical Resources and Tools

The Risk Science Center develops tools to improve and harmonize the risk assessment process. 

Some resources and tools are under underdevelopment.

 

Pharmaceuticals in the Environment (PiE) Support

Pharmaceuticals in the EnvironmentWe can evaluate the relative toxicological risk of pharmaceuticals in the environment, including regulatory clean-up and compliance, product stewardship, aquatic and environmental fate, transformation, and exposure.  We have a large network of ecological toxicologists with a range of expertise that can help solve all PiE related problems.

 

  • Pharmaceutical Risk Assessment Regulatory Reference List - coming soon
  • Rat and Mouse Default Values for Body Weight, Food and Water Consumption - coming soon
  • Inhalation Related Dosimetric Adjustment - coming soon
  • Benchmark Dose Modeling - coming soon 
  • Pharmacokinetic Calculator - coming soon
  • Safe Dose Calculators - coming soon
  • Search Strategy SOP - coming soon

 

Pharma Guidance Documents

General Impurities

Genotoxic Impurities

 

Specific Types of Impurities

 

Shared Facilities

 

Occupational Exposure/Clean Limits.

 

Additional Pharmaceutical Risk Assessment Resources