---
title: "REF: Bioanalytical Testing Considerations"
slug: "ref-bioanalytical-testing-considerations"
updated: 2026-08-13T17:38:50Z
published: 2026-08-13T17:38:50Z
canonical: "bgtcplaybook.document360.io/ref-bioanalytical-testing-considerations"
---

> ## Documentation Index
> Fetch the complete documentation index at: https://bgtcplaybook.document360.io/llms.txt
> Use this file to discover all available pages before exploring further.

# REF: Bioanalytical Testing Considerations

1. [FDA Guidance for Industry: Bioanalytical Method Validation, May 2018](https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf)

2. [FDA Guidance for Industry: Human Gene Therapy for Rare Disease, January 2020](https://www.fda.gov/media/113807/download)

3. BGTC Bioanalytical Strategy, June 2025

4[. FDA Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products, November 2013](https://www.fda.gov/media/87564/download)

5. [FDA Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products, August 2015](https://www.fda.gov/media/89036/download)

6. [Chemistry, Manufacturing & Control Information for Human Gene Therapy Investigational New Drug Applications Guidance for Industry 1/2020](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/chemistry-manufacturing-and-control-cmc-information-human-gene-therapy-investigational-new-drug)

7. [Potency Test for Cellular and Gene Therapy Products 1/2011](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/potency-tests-cellular-and-gene-therapy-products)

8. [Intracellular Cytokine Staining](https://www.sciencedirect.com/topics/immunology-and-microbiology/intracellular-cytokine-staining)

9. [qPCR and qRT-PCR analysis](https://www.cell.com/molecular-therapy-family/advances/fulltext/S2329-0501%2820%2930234-5)