Total pathway to method validation-Reference-Cited by-同舟云学术

Total pathway to method validation

Published:2020-07-01 Issue:11 Volume:58 Page:e257-e261
ISSN:1434-6621
Container-title:Clinical Chemistry and Laboratory Medicine (CCLM)
language:en
Short-container-title:

Author:

Woollard Gerald¹²,McWhinney Brett¹³,Greaves Ronda F.¹⁴⁵⁶⁷^ORCID,Punyalack Wilson¹⁸

Affiliation:

1. Member RCPAQAP-AACB Advisory Committees , St Leonards , NSW , Australia

2. Department of Pathology and Laboratory Medicine , Auckland City Hospital , Auckland , New Zealand

3. Analytical Chemistry Unit , Department of Chemical Pathology , RBWH , Herston , QLD , Australia

4. Victorian Clinical Genetics Services , Murdoch Children’s Research Institute , Parkville , VIC , Australia

5. Department of Paediatrics , University of Melbourne , Melbourne , VIC , Australia

6. School of Health and Biomedical Sciences , RMIT University , Melbourne , VIC , Australia

7. Executive, Emerging Technologies Division , International Federation of Clinical Chemistry and Laboratory Medicine , Milan , Italy

8. The Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) , St Leonards , NSW , Australia

Publisher

Walter de Gruyter GmbH

Subject

Biochemistry (medical),Clinical Biochemistry,General Medicine

Link

https://www.degruyter.com/document/doi/10.1515/cclm-2020-0525/pdf

Reference7 articles.

1. Lippi, G, Plebani, M. A modern and pragmatic definition of Laboratory Medicine. Clin Chem Lab Med 2020;58:1171.

2. Jassam, N, Lake, J, Dabrowska, M, Queralto, J, Rizos, D, Lichtinghagen, R, et al. The European Federation of Clinical Chemistry and Laboratory Medicine syllabus for postgraduate education and training for Specialists in Laboratory Medicine: version 5. Clin Chem Lab Med 2018;56:1846–63. http://dx.doi.org/10.1515/cclm-2018-0344.

3. Greaves, RF, Smith, JM, Beastall, G, Florkowski, C, Langman, L, Sheldon, J, et al. The IFCC curriculum-phase 1. EJIFCC 2018;29:55–93.

4. Chandran, S, Singh, RS. Comparison of various international guidelines for analytical method validation. Pharmazie 2007;62:4–14. http://dx.doi.org/10.1691/ph2007.1.5064.

5. Meesters, R, Voswinkel, S. Bioanalytical method development and validation: from the USFDA 2001 to the USFDA 2018 Guidance for Industry. J Appl Bioanal 2018;4:67–73. https://doi.org/10.17145/jab.18.010.

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