Notas del episodio
This episode delves into the crucial role of analytical methods in ensuring formulation integrity, potency, and performance. It discusses key techniques used for product release and stability assessment, highlighting industry standards and regulatory expectations. Real-world examples and case studies illustrate the challenges and solutions encountered in formulation analysis. The episode emphasizes the importance of precise and accurate analytical methods for safeguarding drug quality.
Beyond simply testing the final product, analytical methods are integral throughout the entire drug development process. The discussion highlights the importance of validating analytical methods to ensure their accuracy, precision, specificity, sensitivity, and robustness. The episode explores various analytical techniques, including chromatography, spectrosc ...