Chemical Synthesis
This service provides chemical synthesis of lead compounds for use in additional drug development studies. Compounds must previously have been successfully synthesized to be candidates for this service. Synthesis of new analogs is not supported.
- Investigators provide the synthetic schemes to be followed; NIAID contractors will modify or optimize problematic steps as necessary.
- Complexity and cost will limit potential scale-up efforts, but synthesis of up to 1 kilogram of a simple small molecule often can be accommodated.
- Synthesis of radiolabeled compounds can be accommodated on a limited basis.
- Drug metabolites and reference standards for analytical assays can be synthesized.
- Drug substances can be synthesized under GMP guidelines.
The current contractor for this service is Starks Associates, Inc., Buffalo, New York.
Analytical Chemistry
This service can be used to develop and perform a variety of analytical assays to assess the properties of drug substances and their formulations.
- Chemical structure and compound purity can be verified.
- Analytical methods to quantitate drug substances in pharmaceutical dosage formulations and biological samples of animal origin can be developed and validated.
- Physical and chemical properties of bulk drug substances and pharmaceutical dosage formulations can be determined.
- Studies can be conducted under GLP or GMP guidelines.
The current contractor for this service is SRI International, Menlo Park, California.
Drug Formulation and Manufacturing
This service can be used to develop, manufacture, and assess a variety of pharmaceutical dosage formulations.
- Physical and chemical properties of bulk drug substances targeted for formulation development can be determined.
- Formulations can be developed to enhance drug solubility, improve bioavailability, enhance drug stability, deliver to target tissues, and treat specific patient populations.
- Formulations can include tablets, capsules, semi-solid preparations, and sustained-release products.
- Stability and release properties of formulations can be evaluated in vitro.
- Formulations can be manufactured, packaged, labeled, and shipped under GMP guidelines.
- Long-term stability studies of manufactured formulations can be conducted.
The current contractor for this service is SRI International, Menlo Park, California.
Animal Pharmacology and Toxicology
This service can be used to provide pharmacokinetic and safety assessments of products in mice, rats, rabbits, dogs, and nonhuman primates.
They following types of studies can be conducted:
- Quantitation of drug and metabolite levels in plasma
- Determination of bioavailability and other pharmacokinetic parameters
- Evaluation of products as substrates, inhibitors, or inducers of cytochrome P450 enzymes
- In vitro genetic toxicity assessments (e.g., Ames test)
- Determination of maximum tolerated dose
- Determination of systemic and specific target-organ toxicity following single or multiple administrations of product
- Studies can be conducted under GLP guidelines
The current contractor for this service is SRI International, Menlo Park, California.