# BIOLOGICAL TESTING FACILITY (BTF) - NONCLINICAL MALE CONTRACEPTIVE DEVELOPMENT SERVICES

> **NIH NIH N01** · SRI INTERNATIONAL · 2022 · $352,571

## Abstract

The Contraception Research Branch (CRB) within the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) supports research to develop compounds that can disrupt oogenesis, spermatogenesis, normal ovulation, sperm maturation and/or function affording safe and effective contraceptives that can be implemented for men and/or women. The Biological Testing Facility (BTF) is designed to permit rapid evaluation of new compositions-of- matter, drug formulations, delivery systems, and devices for contraceptive activity. The BTF provides overall project management and the capabilities to support all phases of nonclinical activities pursuant to development of new contraceptives methods: these include, but are not limited to in vitro and in vivo assays, plasma and microsomal stability studies, absorption, distribution, metabolism, excretion (ADME), toxicity, 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) or Investigational Device Exemption (IDE) applications. The BTF has the capability to prepare compounds under current Good Manufacturing Practices (cGMP) to allow clinical evaluation. The Biological Testing Facility plays a critical role in the product development mission of the CRB.

## Key facts

- **NIH application ID:** 10705348
- **Project number:** 75N94020D00003-0-759402200005-1
- **Recipient organization:** SRI INTERNATIONAL
- **Principal Investigator:** DEBRA BURNIN
- **Activity code:** N01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $352,571
- **Award type:** —
- **Project period:** 2022-09-12 → 2024-09-11

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10705348

## Citation

> US National Institutes of Health, RePORTER application 10705348, BIOLOGICAL TESTING FACILITY (BTF) - NONCLINICAL MALE CONTRACEPTIVE DEVELOPMENT SERVICES (75N94020D00003-0-759402200005-1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10705348. Licensed CC0.

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