Robustness testing of live attenuated rubella vaccine potency assay using fractional factorial design of experiments-Reference-Cited by-同舟云学术

Robustness testing of live attenuated rubella vaccine potency assay using fractional factorial design of experiments

Published:2010-07 Issue:33 Volume:28 Page:5497-5502
ISSN:0264-410X
Container-title:Vaccine
language:en
Short-container-title:Vaccine

Author:

Kutle Leonida,Pavlović Nediljko,Dorotić Marko,Zadro Ivana,Kapustić Marijana,Halassy Beata

Funder

Croatian Ministry of Science, Education and Sports

Publisher

Elsevier BV

Subject

Infectious Diseases,Public Health, Environmental and Occupational Health,General Veterinary,General Immunology and Microbiology,Molecular Medicine

Reference16 articles.

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3. United States Pharmacopeia. <1225> Validation on compendial procedures. In: U.S. Pharmacopeia 31 – NF 26, vol. 1; 2008. p. 683–687.

4. World Health Organisation. Validation of analytical assays. In: A WHO Guide to Good Manufacturing Practice (GMP) Requirements WHO/VSQ/97.02; 1997. p. 69.

5. Guidance for robustness/ruggedness tests in method validation;Vander Heyden;J Pharm Biomed Anal,2001

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