Method Development & Validation Of Drugs By Chromatographic Technique - Dubey, Som Shankar;Duggirala, Mahesh
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In the pharmaceutical industry, the quality control and quality assurance play major role in bringing out a safe and effective drug or dosage form. The pharmaceutical industry has delivered market safe, efficacious product that fulfills medical needs of the public.Development of new analytical methods for the determination of drugs quantitatively and qualitatively in pharmaceutical dosage forms is more important in pharmacokinetics, toxicological and biological studies. The current good manufacturing practices (CGMP) and the Food Drug Administration (FDA) guidelines insist for adoption of…mehr

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Produktbeschreibung
In the pharmaceutical industry, the quality control and quality assurance play major role in bringing out a safe and effective drug or dosage form. The pharmaceutical industry has delivered market safe, efficacious product that fulfills medical needs of the public.Development of new analytical methods for the determination of drugs quantitatively and qualitatively in pharmaceutical dosage forms is more important in pharmacokinetics, toxicological and biological studies. The current good manufacturing practices (CGMP) and the Food Drug Administration (FDA) guidelines insist for adoption of sound methods of analysis with greater sensitivity and reproducibility. Pharmaceutical analysis occupies a pivotal role in statuary certification of drugs and their formulations either by the industry or by the regulatory authorities. Therefore, the complexity of problems encountered in pharmaceutical analysis with the importance of achieving the selectivity, speed, low cost, simplicity, sensitivity, specificity, precision and accuracy in estimation of drugs.
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Autorenporträt
Dr. Som Shankar Dubey is currently working in Deen Dayal Upadhaya Gorakhpur University, Uttar Pradesh in the field of synthesis of nano materials and study of their potential application for adsorption and recovery of rare earth elements. Dr. Sarika Grandhi is post doctoral fellow at Gitam University, Visakhapatnam, Andhra Pradesh, India.