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NeuroScience Associates

NSA Safety Protocols

NSA’s FDA Neurotoxicity Presentation 2015


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 the following general approaches to neuropathologic safety testing:   * “NeuroSafety Certification,”   * “Neurotoxicity Screening,”  and   * “NMDA Receptor Antagonists Certification”.

* NeuroSafety Certification

NSA Certification Studies are GLP-compiant predefined protocols designed specifically to evaluate compounds for meeting safety regulatory requirements, addressing any specific safety concerns for particular classes of compounds.

* Neurotoxicity Screening

NSA Neurotoxicity Screening protocols provide a strategic tool (including a Disintegrative Degeneration Stain) during the R&D cycle, offering valuable decision-making data by identifying high-risk or non-viable compounds early.  In “weeding-out” non-viable compounds, resources can be directed toward modifications and/or refocusing on other viable candidates, reducing development cycle and regulatory approval timelines

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.”

* NMDA Receptor Antagonist Certification

NSA’s Receptor Antagonist Certification GLP Study design is created specifically for meeting the FDA’s latest testing requirement entitled “RECOMMENDATIONS FOR THE DEVELOPMENT OF NMDA RECEPTOR ANTAGONISTS”.  This is based on an Agency letter dated January 27, 1995 regarding safety concerns discovered with MK-801.  The FDA provides this document to sponsors that are submitting a compound for approval in this class of compounds.

Good Laboratory Practices (GLP)

NSA has extensive experience performing all services compliant with GLP, defined as Good Laboratory Practices as promulgated by USFDA 21CFR Part 58, USEPA and OECD.  NSA utilizes an independent auditor with over 30 years of Quality Assurance (QA) experience, who provides services related to all GLP regulated studies that are performed.

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 are GLP trained.  While all GLP studies include QA, requests are welcome for including QA to non-GLP studies as well. Adding QA to a study offers an independent review of the data and reporting for accuracy and completeness.   To discuss QA options contact NSA.

Learn more about NSA and NeuroSafety:

NeuroSafety Overview Approach

Chemical Changes Evaluation

Perturbations/Inflammation Evaluation

Permanent Damage Evaluation

Neonate/Juvenile Safety Studies Approach