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Evaluation and Recommendations on Good Clinical Laboratory Practice Guidelines for Phase I–III Clinical Trials


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Vyšlo v časopise: Evaluation and Recommendations on Good Clinical Laboratory Practice Guidelines for Phase I–III Clinical Trials. PLoS Med 6(5): e32767. doi:10.1371/journal.pmed.1000067
Kategorie: Guidelines and Guidance
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pmed.1000067

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Zdroje

1. Code of Federal Regulations 2005 21 CFR Part 58. Good laboratory practice for nonclinical laboratory studies. Available: http://www.access.gpo.gov/nara/cfr/waisidx_05/21cfr58_05.html. Accessed 31 March 2009

2. Code of Federal Regulations 2005 42 CFR Part 493. Laboratory requirements. Available: http://www.access.gpo.gov/nara/cfr/waisidx_05/42cfr493_05.html. Accessed 31 March 2009

3. College of American Pathologists 2009 Surveys and anatomic pathology education programs. Available: http://www.cap.org/apps/cap.portal?_nfpb=true&_pageLabel=education. Accessed 31 March 2009

4. International Organization for Standardization 2003 ISO 15189: Medical laboratories—Particular requirements for quality and competence. Available: http://www.iso.org/iso/en/CatalogueDetailPage.CatalogueDetail?CSNUMBER=26301. Accessed 31 March 2009

5. European Medicines Agency 1996 ICH topic E6 guideline for good clinical practice. Step 5, consolidated guideline. CPMP/ICH/135/95. Available: http://www.emea.europa.eu/pdfs/human/ich/013595en.pdf. Accessed 6 April 2009

6. StilesT

GrantV

MawbeyN

2003 Good clinical laboratory practice (GCLP): A quality system for laboratories which undertake the analyses of samples from clinical trials. Ipswich (UK): British Association of Research Quality Assurance 1 17 ISBN 1-904610-00-5

7. EzzelleJ

Rodriguez-ChavezIR

DardenJM

StirewaltM

KunwarN

2008 Guidelines on good clinical laboratory practice: Bridging operations between research and clinical research laboratories. J Pharm Biomed Anal 46 18 29

8. KlausnerRD

FauciAS

CoreyL

NabelGJ

GayleH

2003 The need for a global HIV vaccine enterprise. Science 300 2036 2039

9. StevensW

2003 Good clinical laboratory practice (GCLP): The need for a hybrid of good laboratory practice and good clinical practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries. Qual Assur 10 83 89

10. GilmourJW

StevensW

GrayC

De SouzaM

2007 Laboratory expansion to large-scale international HIV preventive vaccine trials. Curr Opin HIV AIDS 2 201 206

11. International Conference on Harmonisation 1995 Guideline for industry: Text on validation of analytical procedures. ICH-Q2A: 1-4. Available: http://www.fda.gov/cder/Guidance/ichq2a.pdf. Accessed 31 March 2009

12. ICH Tripartite Guideline 2005 Validation of analytical procedures: Text and methodology. Q2(R1): 1-13. Available: http://www.ich.org/cache/compo/276-254-1.html. Accessed 6 April 2009

13. ThomasSJ

HombachJ

BarrettA

2009 Scientific consultation on cell mediated immunity (CMI) in dengue and dengue vaccine development. Vaccine 27 355 368

14. D'SouzaP

CoxJH

FerrariG

Thapa KunwarN

PolonisV

2008 Endpoint assays in HIV-1 vaccine trials: Functioning in a good laboratory practices environment.

PrabhakarU

KelleyM

Validation of cell-based assays in the GLP setting: A practical guide Chichester (UK) John Wiley 239 275

15. Sarzotti-KelsoeM

2007 Regional chapter news: NCCSQA GCLP workshop review. Qual Matters 23 13

16. HortonH

ThomasEP

StuckyJA

FrankI

MoodieZ

2007 Optimization and validation of an 8-color intracellular cytokine staining (ICS) assay to quantify antigen-specific T cells induced by vaccination. J Immunol Methods 323 39 54

17. LandayAL

FleischerTA

Kuus-ReichelK

MainoVC

ReinsmoenN

2004 Performance of single cell immune response assays: Approved guideline. Clinical and Laboratory Standards Institute 24 1 71

18. MaeckerHT

HasslerJ

PayneJK

SummersA

ComatasK

2008 Precision and linearity targets for validation of an IFNgamma ELISPOT, cytokine flow cytometry, and tetramer assay using CMV peptides. BMC Immunol 9 9

19. XuY

TheobaldV

SungC

DePalmaK

AtwaterL

2008 Validation of a HLA-A2 tetramer flow cytometric method, IFNgamma real time RT-PCR, and IFNgamma ELISPOT for detection of immunologic response to gp100 and MelanA/MART-1 in melanoma patients. J Transl Med 6 61 doi:10.1186/1479-5876-6-61

20. TholenDW

BerteLM

CooperWG

Gun-MunroJ

NobleMA

2007 Using proficiency testing to improve the clinical laboratory: Approved guideline—Second edition. Clinical Laboratory Standards Institute 27 1 41

21. CoxJH

FerrariG

KalamsS

LopaczynskiW

OdenN

2005 Results of an ELISPOT proficiency panel conducted in 11 laboratories participating in international human immunodeficiency virus type 1 vaccine trials. AIDS Res Hum Retroviruses 21 68 81

22. JanetzkiS

PanageasKS

Ben-PoratL

BoyerJ

BrittenCM

2008 Results and harmonization guidelines from two large-scale international Elispot proficiency panels conducted by the Cancer Vaccine Consortium (CVC/SVI). Cancer Immunol Immunother 57 303 315

23. BoazMJ

HayesP

TarragonaT

SeamonsL

CooperA

2009 Concordant proficiency in measurement of T-cell immunity in human immunodeficiency virus vaccine clinical trials by peripheral blood mononuclear cell and enzyme-linked immunospot assays in laboratories from three continents. Clin Vaccine Immunol 16 147 155

24. Sarzotti-KelsoeM

OzakiDA

GreeneK

Rodriguez-ChavezIR

AhlersJ

2007 Establishing an international proficiency testing program for anti-HIV-1 neutralizing antibody assay. Qual Assur J 11 46 47

25. BrittenCM

JanetzkiS

van der BurgSH

GouttefangeasC

HoosA

2008 Toward the harmonization of immune monitoring in clinical trials: Quo vadis? Cancer Immunol Immunother 57 285 288

26. DisisML

2004 Assay validation for vaccine potency assessment [presentation]. Immune Monitoring Workshop II; 4 November 2004; San Francisco, CA, United States. Available: http://www.isbtc.org/meetings/am04/workshop_presentations/disis.pdf. Accessed 31 March 2009

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