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Items: 1 to 20 of 105

1.

Guidelines on good clinical laboratory practice: bridging operations between research and clinical research laboratories.

Ezzelle J, Rodriguez-Chavez IR, Darden JM, Stirewalt M, Kunwar N, Hitchcock R, Walter T, D'Souza MP.

J Pharm Biomed Anal. 2008 Jan 7;46(1):18-29. Epub 2007 Oct 13.

3.

Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL).

Todd CA, Sanchez AM, Garcia A, Denny TN, Sarzotti-Kelsoe M.

J Immunol Methods. 2014 Jul;409:91-8. doi: 10.1016/j.jim.2013.09.012. Epub 2013 Oct 9. Review.

4.

Quality management of pharmacology and safety pharmacology studies.

Spindler P, Seiler JP.

Fundam Clin Pharmacol. 2002 Apr;16(2):83-90.

PMID:
12031061
5.

Benefits of a comprehensive quality program for cryopreserved PBMC covering 28 clinical trials sites utilizing an integrated, analytical web-based portal.

Ducar C, Smith D, Pinzon C, Stirewalt M, Cooper C, McElrath MJ, Hural J; NIAID HIV Vaccine Trials Network.

J Immunol Methods. 2014 Jul;409:9-20. doi: 10.1016/j.jim.2014.03.024. Epub 2014 Apr 4.

6.

Quality assurance responsibilities as defined by the EPA Good Automated Laboratory Practices (GALPs).

Fielder FG, Eleuteri BA, Gross EM.

Qual Assur. 1993 Mar-Jun;2(1-2):175-9.

PMID:
8156208
7.

American Society of Clinical Oncology Statement on minimum standards and exemplary attributes of clinical trial sites.

Zon R, Meropol NJ, Catalano RB, Schilsky RL.

J Clin Oncol. 2008 May 20;26(15):2562-7. doi: 10.1200/JCO.2007.15.6398. Epub 2008 Apr 7.

PMID:
18390967
8.
9.

The External Quality Assurance Oversight Laboratory (EQAPOL) proficiency program for IFN-gamma enzyme-linked immunospot (IFN-γ ELISpot) assay.

Sanchez AM, Rountree W, Berrong M, Garcia A, Schuetz A, Cox J, Frahm N, Manak M, Sarzotti-Kelsoe M, D'Souza MP, Denny T, Ferrari G.

J Immunol Methods. 2014 Jul;409:31-43. doi: 10.1016/j.jim.2014.03.017. Epub 2014 Mar 28.

10.

Good laboratory practices for biochemical genetic testing and newborn screening for inherited metabolic disorders.

Centers for Disease Control and Prevention (CDC).

MMWR Recomm Rep. 2012 Apr 6;61(RR-2):1-44.

11.

The Pathology Laboratory Act 2007 explained.

Looi LM.

Malays J Pathol. 2008 Jun;30(1):1-10. Review.

12.

EPA's GLP compliance review of chemistry laboratories.

Hill DF.

Qual Assur. 1993 Mar-Jun;2(1-2):78-84.

PMID:
8156226
14.

Required steps for the validation of a Laboratory Information Management System.

Turner E, Bolton J.

Qual Assur. 2001 Jul-Dec;9(3-4):217-24.

PMID:
12553085
15.

Laboratory challenges conducting international clinical research in resource-limited settings.

Fitzgibbon JE, Wallis CL.

J Acquir Immune Defic Syndr. 2014 Jan 1;65 Suppl 1:S36-9. doi: 10.1097/QAI.0000000000000038.

16.

Saving laboratory records: what, how, how long?

Baer D.

MLO Med Lab Obs. 2004 May;36(5):10-1, 14-6; quiz 18-20. No abstract available. Erratum in: MLO Med Lab Obs. 2004 Jun;36(6):16.

PMID:
15179913
17.

Introduction to ISO 15189: a blueprint for quality systems in veterinary laboratories.

Freeman KP, Bauer N, Jensen AL, Thoresen S.

Vet Clin Pathol. 2006 Jun;35(2):157-71.

PMID:
16783708
18.

ASVCP quality assurance guidelines: control of general analytical factors in veterinary laboratories.

Flatland B, Freeman KP, Friedrichs KR, Vap LM, Getzy KM, Evans EW, Harr KE.

Vet Clin Pathol. 2010 Sep;39(3):264-77. doi: 10.1111/j.1939-165X.2010.00251.x.

PMID:
21054473
19.

Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies.

Andrade EL, Bento AF, Cavalli J, Oliveira SK, Schwanke RC, Siqueira JM, Freitas CS, Marcon R, Calixto JB.

Braz J Med Biol Res. 2016 Dec 12;49(12):e5646. doi: 10.1590/1414-431X20165646. Review.

20.

Good Automated Laboratory Practices.

Weinberg S.

Qual Assur. 1993 Mar-Jun;2(1-2):62-6. No abstract available.

PMID:
8156223

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