This service can be used to develop and perform a variety of analytical assays to assess the properties of drug substances and their formulations.
Main Areas of Focus
- To fill specific gaps in an investigator’s drug development plan as they advance their product towards clinical investigation
- To help investigators obtain data to get additional funding
- To help with prospective partnerships
- To help getting regulatory permission to continue
- Chemical structure and compound purity can be verified.
- Analytical methods to quantitate drug substances in pharmaceutical dosage formulations.
- Physical and chemical properties of bulk drug substances and pharmaceutical dosage formulations can be determined.
- Studies can be conducted under GLP or GMP guidelines.
Investigators seeking these services receive no funding from NIAID, but instead receive products or information generated by NIAID-funded contractors on their behalf.
Who Can Use This Resource
- Product must be defined and of known chemical structure.
- Investigator must have preliminary data to support the continued development of product.
How To Get Started
- Follow the procedures for requesting access to NIAID contract services.
- In addition, data packages for Analytical Chemistry Services should address the following items:
- Availability of API reference standard
- Previous efforts to develop analytical methods for the product and difficulties encountered