Assay and Screening
The purpose of assay development & screening in drug development is to take investigative measures that assess a compound qualitatively or examine a compound's effects on identified cellular, molecular, or biochemical targets. The primary step in drug development are the detection and confirmation of potential drug targets involved in human disease. These targets are usually either a cellular structure or specific protein.
- Nuclear Receptors
- Ion Channels
- Hormones and factors
Developing top-notch screening assay is vital to drug discovery and development. The main factors to consider in assay development & screening are - relevance, quality, reproducibility, cost and interference. The process of documenting/proving that an analytical method provides analytical is known as the analytical method validation. A pharmaceutical drug product must meet all its conditions throughout its entire shelf-life. Analytical method development and validation are conducted throughout the drug development process continuously and are interconnected activities. The practice of analytical method validation verifies that a particular method measures a parameter as intended and establishes the performance limits of the measurement.
So, why is analytical method validation important? It helps us to understand the crucial process parameters and to minimize their influence on accuracy and precision.
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