Total pathway to method validation

Gerald Woollard^{1

2}, Brett McWhinney^{1

3}, Ronda F Greaves^{1

4

5

6

7}, Wilson Punyalack^{1

8}

Affiliations

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.

Free article

Gerald Woollard et al. Clin Chem Lab Med. 2020.

Free article

. 2020 Oct 25;58(11):e257-e261.

doi: 10.1515/cclm-2020-0525.

Gerald Woollard^{1

2}, Brett McWhinney^{1

3}, Ronda F Greaves^{1

4

5

6

7}, Wilson Punyalack^{1

8}

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.

No abstract available

Keywords: development; method validation; post-development; pre-developmental.

References

1. Lippi, G, Plebani, M. A modern and pragmatic definition of Laboratory Medicine. Clin Chem Lab Med 2020;58:1171.
1. 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.
1. Greaves, RF, Smith, JM, Beastall, G, Florkowski, C, Langman, L, Sheldon, J, et al. The IFCC curriculum-phase 1. EJIFCC 2018;29:55–93.
1. 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.
1. 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.