Biomedical Engineering Reference
In-Depth Information
U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center
for Veterinary Medicine (CVM), May 2001, Guidance for industry—bioanalytical method
validation.
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/
The United States Pharmacopeia-National Formulary (USP-NF), USP34-NF29 S1.
General
Requirements/
<11>USP Reference Standards, pp 38-40. Pharmacopeial Forum 35(6):1507
The United States Pharmacopeia-National Formulary (USP-NF), USP34-NF29 S1.
General
Information/
<1225>Validation of Compendial Procedures, pp 779-782. Pharmacopeial Forum
35(2):444
U.S. Environmental protection agency CFR—Code of Federal Regulations Title 40—Protection of
Environment PART 792—Good laboratory practice standards.
http://www.access.gpo.gov/
U.S. Environmental protection agency, Chemical QC guidelines.
http://www.epa.gov/sam/qc-
The National Institute of Standards and Technology, Analytical chemistry division, Development
of Reference Methods and Reference Materials for the Determination of Hormones in Human
Serum.
http://www.nist.gov/mml/analytical/organic/hormonesinserum.cfm
The National Institute of Standards and Technology, Taylor BN, Kuyatt CE (1994) Guidelines for
evaluating and expressing the uncertainty of NIST measurement results. NIST Technical Note
1297, pp 1-20.
http://www.nist.gov/pml/pubs/tn1297/index.cfm
Thomson M, Ellison SLR, Wood R (2002) International union of pure and applied chemistry,
harmonized guidelines for single laboratory validation of method of analysis. Pure Appl
Chem
7
4:835-855.
http://www.iupac.org/objID/Article/pac7405x0835
International Organization of Standardization, Guide:
ISO Guide 30:1992 Terms and definitions used in connection with reference materials
ISO Guide 30:1992/Amd 1:2008 Revision of definitions for reference material and certified refer-
ence material
ISO Guide 31:2000 Reference materials—contents of certificates and labels
ISO Guide 32:1997 Calibration in analytical chemistry and use of certified reference materials
ISO Guide 33:2000 Uses of certified reference materials
ISO Guide 34:2009 General requirements for the competence of reference material producers
ISO Guide 35:2006 Reference materials—general and statistical principles for certification.
http://
International Organization of Standardization, Published:
ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results—Part 1:
general principles and definitions
ISO 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results—Part 2:
basic method for the determination of repeatability and reproducibility of a standard measure-
ment method
ISO 5725-3:1994 Accuracy (trueness and precision) of measurement methods and results—Part 3:
intermediate measures of the precision of a standard measurement method
ISO 5725-4:1994 Accuracy (trueness and precision) of measurement methods and results—Part 4:
basic methods for the determination of the trueness of a standard measurement method
