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ASSAY DOCKET GUIDANCE Customer details to be filled out in this section as below. Account No. should be entered by the customer. It is available on all invoices and begins with a letter, e.g. T0060.

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How to fill out hts assay validation

01

Assemble all necessary materials and reagents for the assay validation process.

02

Prepare the assay plates according to the protocol provided by the manufacturer.

03

Add the test compounds or samples to the designated wells on the assay plates.

04

Incubate the assay plates for the specified amount of time at the appropriate temperature.

05

Follow the assay protocol for detection and data analysis to determine the assay validation parameters.

Who needs hts assay validation?

01

Pharmaceutical companies developing new drugs

02

Research laboratories studying drug targets

03

Contract research organizations offering screening services

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What is hts assay validation?

HTS assay validation is the process of confirming that a high-throughput screening (HTS) assay is reliable, accurate, and robust.

Who is required to file hts assay validation?

Those conducting high-throughput screening assays are required to file HTS assay validation.

How to fill out hts assay validation?

HTS assay validation can be filled out by providing detailed information on the methodology, results, and statistical analysis of the assay.

What is the purpose of hts assay validation?

The purpose of HTS assay validation is to ensure the reliability and accuracy of the screening process in drug discovery.

What information must be reported on hts assay validation?

HTS assay validation should include details on assay design, validation experiments, quality control measures, and data analysis.

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