# BIOLOGICAL TESTING FACILITY – "QUANTITATIVE STRUCTURE ACTIVITY RELATIONSHIP"

> **NIH NIH N01** · SRI INTERNATIONAL · 2021 · $125,720

## Abstract

Within the Division of Intramural Population Health Research (DIPHR), the Contraceptive
Development Program (CDP) at NICHD supports research and development of compounds that
can disrupt normal ovulation, sperm production or sperm function for the purpose of developing
safe, effective and affordable contraceptives for men or women. The Biological Testing Facility
(BTF) is designed to allow discovery and rapid evaluation of new compositions-of-matter, drug
formulations, delivery systems, and devices for contraceptive and endocrine activity. The BTF
provides overall project management and the capabilities to support all phases of preclinical
activities pursuant to development of new contraceptive methods: these include, but are not limited
in silico/computational modeling, to in vitro and in vivo assays, plasma and microsomal stability
studies, absorption, distribution, metabolism, excretion and toxicity (ADMET), pharmacokinetic
(PK) and pharmacodynamic (PD) profiling, animal activities and studies, manufacture of active
pharmaceutical ingredients (APIs), process and product development, formulation, clinical lot
production, preclinical enabling studies and associated tasks leading to the filing of investigational
new drug (IND) applications. Compounds formulated by the BTF that are prepared under current
Good Manufacturing Practices (cGMP) will allow clinical evaluation in the CDP Contraceptive
Clinical Trials Network (CCTN). The CCTN investigators have develop protocols to evaluate the
drug candidates identified as high priority by the Program. The BTF has been working with the
CORs for the Chemical Synthesis Facility (CSF) and the CCTN and with the investigators in the
CCTN to develop and test the appropriate formulations for clinical batches of the candidate
compounds. The Biological Testing Facility plays a critical role in the drug development mission
of the CDP.

## Key facts

- **NIH application ID:** 10361636
- **Project number:** 75N94020D00003-0-759402100001-1
- **Recipient organization:** SRI INTERNATIONAL
- **Principal Investigator:** DEBORAH BUNIN
- **Activity code:** N01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $125,720
- **Award type:** —
- **Project period:** 2021-01-07 → 2022-01-06

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10361636

## Citation

> US National Institutes of Health, RePORTER application 10361636, BIOLOGICAL TESTING FACILITY – "QUANTITATIVE STRUCTURE ACTIVITY RELATIONSHIP" (75N94020D00003-0-759402100001-1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10361636. Licensed CC0.

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