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THE UNIVERSITY OF CENTRAL OKLAHOMA Edmond, OK Jackson College of Graduate StudiesMethod Development and Validation for Drug Identification and Confirmation by LC/SMS for Limited specimen Cases THESIS

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How to fill out method development and validation

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Define the purpose and objectives of the method development and validation process.

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Choose an appropriate analytical technique or method for the analysis.

03

Develop a detailed experimental plan including sample preparation, analysis parameters, and acceptance criteria.

04

Conduct preliminary testing to optimize the method parameters.

05

Perform method validation studies to demonstrate the reliability and accuracy of the method.

06

Document all the steps and results of the method development and validation process.

Who needs method development and validation?

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Pharmaceutical companies for drug development and quality control purposes.

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What is method development and validation?

Method development and validation is the process of establishing reliable and reproducible analytical methods for testing the identity, strength, purity, and quality of a substance.

Who is required to file method development and validation?

Manufacturers, researchers, and laboratories are required to file method development and validation.

How to fill out method development and validation?

Method development and validation forms can be filled out online through the designated submission portal.

What is the purpose of method development and validation?

The purpose of method development and validation is to ensure that analytical methods are accurate, precise, and reliable for testing the quality of substances.

What information must be reported on method development and validation?

Information on the development process, validation protocols, data analysis, and results must be reported on method development and validation.

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