# Assay Core

> **NIH NIH P01** · UNIVERSITY OF FLORIDA · 2020 · $313,924

## Abstract

Project Summary and Abstract 
The College of Pharmacy (COP) Infectious Disease Pharmacokinetics Laboratory (IDPL) at the 
University of Florida (UF) has vast experience in developing, validating and performing bioanalytical 
assays. The lab is CLIA licensed, and College of American Pathologists (CAP) inspected and certified 
biannually. The lab also follows CFR Part 58 (Good Laboratory Practice for Nonclinical laboratory 
studies) and follows relevant FDA Guidances for Industry (e.g. the newest Bioanalytical assay 
validation guidance) for work requiring that degree of compliance. The lab has provided analytical work 
for Industry and FDA that conforms to standards acceptable for regulatory submission. The IDPL is set 
up with state of the art equipment and data management systems, as well as SOPs, outlining 
procedures for accepting and repeating analytical runs or samples. 
The IDPL has considerable experience in preparing analytical and pharmacokinetic reports. This 
includes assay reports, as well as non-compartmental, compartment analysis, and population 
pharmacokinetic analysis. Charles Peloquin, Pharm.D. provides expertise in analytical and 
pharmacokinetic evaluation of drug action. The IDPL, during its 27 years of existence, has substantial 
experience in providing results of assay development and validation to sponsors. This includes 
submission of raw data, assay validation results and validation protocols and reports. Assay 
development and validation, as well as data transfer will be performed according to relevant FDA Draft 
Guidance for Industry. [1-3] 
For this project, the IDPL will develop all of the necessary assays and validate them in several 
matricies, including hollow fiber system (HFS) broth, animal plasma, and animal BAL fluid in support of 
the experiments described in other sections. The IDPL will communicate these results on a timely basis 
to the other Cores involved in the project.

## Key facts

- **NIH application ID:** 9993192
- **Project number:** 5P01AI123036-05
- **Recipient organization:** UNIVERSITY OF FLORIDA
- **Principal Investigator:** Charles Arthur Peloquin
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $313,924
- **Award type:** 5
- **Project period:** 2016-08-20 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9993192

## Citation

> US National Institutes of Health, RePORTER application 9993192, Assay Core (5P01AI123036-05). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/9993192. Licensed CC0.

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