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NeuroScience Associates

NSA Safety Protocols

NSA has generic protocols designed to meet common safety testing needs and NSA offers assistance in the design and execution of custom designed safety testing protocols. NSA offers two general approaches to neuropathologic safety testing, called “NeuroSafety Certification” and “Neurotoxicity Screening.” Additionally, due to the frequency of requests, NSA has developed a packaged certification protocol to meet the FDA requirements for N-methyl-Daspartic acid (NMDA) receptor antagonists.

NeuroSafety Certification

Certification studies are GLP-compliant protocols designed specifically to evaluate compounds needing to meet regulatory requirements. NSA has predefined protocols that are designed to meet the needs of most clients. These study designs are then customized to meet specific regulatory requirements or to address specific safety concerns of a particular class of compound.

NMDA Receptor Antagonist Certification

The FDA has a testing requirement as specified in an FDA document entitled “RECOMMENDATIONS FOR THE DEVELOPMENT OF NMDA RECEPTOR ANTAGONISTS,” based upon an Agency letter dated January 27, 1995, describing the FDA’s current recommendations for development of NMDA receptor antagonists. The requirements in this document are based upon safety concerns discovered with MK-801, and the FDA now provides this document to sponsors that are submitting a compound for approval in this class of compounds. NSA has developed a GLP safety certification study design created specifically to meet the FDA’s latest interpretation of these requirements.

Good Laboratory Practices (GLP)

NSA is experienced in performing services compliant with GLP for any of the services offered by NSA. GLP is defined as Good Laboratory Practices as promulgated by USFDA 21CFR Part 58, USEPA and OECD. NSA utilizes an independent auditor with over 25 years QA experience to provide services related to all GLP-regulated studies that NSA performs.

Services provided by the auditor include:

  • Inspect facility periodically, provide GLP training to NSA staff, review Standard Operating Procedures (SOPs), review equipment records.
  • Review protocols, inspect work in progress, audit study data, audit study reports, provide QA Statement to Study Director.
  • Report inspection findings to NSA management and to Study Director and testing facility QA.
  • Host visiting QA site visits.

All of NSA’s lab personnel have received GLP training. The addition of QA to your study offers an independent review of the data and report for accuracy and completeness. If yours is a GLP study, QA is included, but all clients are welcome to request QA for their study. To discuss QA for your study, please contact NSA.

Neurotoxicity Screening

While Neurosafety Certifications are performed as a requirement intended to prove the safety of a compound, Neurotoxicity Screens are conducted as a Disintegrative Degeneration stain, a strategic tool during the R&D cycle with the goal of identifying high-risk candidates early. Neurotoxicity screens are rapid, inexpensive tests conducted during preclinical development stages designed to offer valuable decision-making data. Eliminating non-viable compounds early offers a huge potential for R&D cost savings:

Janet Woodcock, previous FDA Director of Center for Drug Evaluation and Research (CDER) stated: “There is not enough research in finding new methods of understanding toxicology at the basic scientific level…. Improving any one of these issues could achieve a 10% improvement in predicting failures before clinical trials and could save $100 million in development costs per drug.”

NSA’s Approach to Neurotoxicity Screening Saves Companies Time and Money

NSA’s screening protocols reduce development cycle times and regulatory approval timelines and enable more effective use of R&D resources. The protocols provide a new mechanism to “weed out” non-viable compounds. Resources can instead be directed toward modifying non-viable compounds, refocused on viable candidates or reassigned to new candidates.

Price of Basic Neurotoxicity Screening: < $5,000 per Compound

The price above reflects NSA’s recommended baseline template protocol that is a rodent study designed to reveal >80% of compounds exhibiting a neurotoxic profile. Pricing may vary depending on protocol variables chosen by each client.

 

Learn more about NSA and neurosafety:

NeuroSafety Assessment

Approach to Neurosafety

Changes: Chemical and Other Abnormal

Perturbations/Inflammation

Permanent Damage

Neonate/Juvenile Studies