Validation of analytical procedures by high−performance liquid chromatography for pharmaceutical analysis

Author:

Kazusaki Masato1,Ueda Shinji1,Takeuchi Naoto1,Ohgami Yasutaka1

Affiliation:

1. Investigational Drug Quality Assurance, Technology Research & Development, Dainippon Sumitomo Pharma Co., Ltd.

Publisher

The Society for Chromatographic Sciences

Subject

General Medicine

Reference13 articles.

1. [1] Inman, E. L.; Frischmann, J. K.; Jimenez, P. J.; Winkle, G. D.; Persinger, M. L.; Rutherford, B. S. J. Chromatogr. Sci. 1987, 25, 252−256.

2. [2] Shah, V. P.; Midha, K. K.; Dighe, S.; McGilverray, I. J.;Skey, J. P.; Yacobi, A.; Layoff, T.; Viswanathan, C. T.; Cook, C. E.; McDowall, R. D.; Pittman, K. A.; Spector, S. Pharma. Res. 1992, 9, 588−592.

3. [3] Green,J.M.Anal. Chem. 1996, 305A−309A.

4. [4] U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Re search (CDER), Center for Veterinary Medicine (CVM). Guidance for Industry, Bioanalytical Method Validation,2001.

5. [5] U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Re search (CDER). Reviewer Guidance, Validation of chromatographic methods, 1994.

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