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Stabilizing drug molecules in biological samples.

Jiwen Chen¹, Yunsheng Hsieh

¹Drug Metabolism and Pharmacokinetics Department, Schering-Plough Research Institute, Kenilworth, New Jersey 07033, USA.

Therapeutic Drug Monitoring

|September 22, 2005

Summary

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Ensuring pharmaceutical stability in biological samples is crucial for drug development and regulatory approval. This review covers methods like temperature control and pH adjustment to overcome drug candidate instability during assay validation.

Area of Science:

Analytical Chemistry
Pharmacology
Drug Development

Background:

Method validation requires assessing stability alongside accuracy, precision, selectivity, and sensitivity.
Instability of drug candidates in biological samples complicates assay validation during drug development.

Purpose of the Study:

To review general strategies and methodologies for stabilizing pharmaceuticals in biological samples.
To address challenges in assay validation due to drug candidate instability.

Main Methods:

Temperature adjustment
pH control
Derivatization techniques
Addition of inhibitors and oxidants

Main Results:

Related Experiment Videos

The reviewed methods are commonly employed to enhance the stability of pharmaceuticals.
These strategies facilitate reliable assay validation for drug candidates.

Conclusions:

Effective stabilization strategies are essential for successful bioanalytical method validation.
Addressing drug candidate instability is critical for the drug approval process.