Bioanalytical method validation and its implications for forensic and clinical toxicology - A review

Accreditation and Quality Assurance

Volumn 7, Issue 11, 2002, Pages 441-449

  Peters, Frank T ^a   Maurer, Hans H ^a  

^a SAARLAND UNIVERSITY   (Germany)

Author keywords

Bioanalysis; Method; Toxicology; Validation

Indexed keywords

ACCREDITATION; ACCURACY; ANALYTIC METHOD; CALIBRATION; FORENSIC SCIENCE; RELIABILITY; REVIEW; THEORETICAL MODEL; TOXICOLOGY; VALIDATION PROCESS;

EID: 0036827348     PISSN: 09491775     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00769-002-0516-5     Document Type: Review

References (20)

1. Karnes HT, Shiu G, Shah VP (1991) Pharm Res 8:421-426
2. Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, Yacobi A, Layloff T, Viswanathan CT, Cook CE, McDowall RD, Pittman KA, Spector S (1992) Pharm Res 9:588-592
3. Hartmann C, Massart DL, McDowall RD (1994) J Pharm Biomed Anal 12:1337-1343
4. Dadgar D, Burnett PE (1995) J Pharm Biomed Anal 14:23-31
5. Dadgar D, Burnett PE, Choc MG, Gallicano K, Hooper JW (1995) J Pharm Biomed Anal 13:89-97
6. Wieling J, Hendriks G, Tamminga WJ, Hempenius J, Mensink CK, Oosterhuis B, Jonkman JH (1996) J Chromatogr A 730:381-394
7. Bressolle F, Bromet PM, Audran M (1996) J Chromatogr B 686:3-10
8. Causon R (1997) J Chromatogr B 689:175-180
9. Hartmann C, Smeyers-Verbeke J, Massart DL, McDowall RD (1998) J Pharm Biomed Anal 17:193-218
10. Shah VP, Midha KK, Findlay JW, Hill HM, Hulse JD, McGilveray IJ, McKay G, Miller KJ, Patnaik RN, Powell ML, Tonelli A, Viswanathan CT, Yacobi A (2000) Pharm Res 17:1551-1557
11. U.S. Department of Health and Human Services, Food and Drug Administration (2001) Guidance for industry, bioanalytical method validation http://www.fda.gov/cder/guidance/index.htm
12. Lindner W, Wainer IW (1998) J Chromatogr B 707:1-2
13. International Conference on Harmonization (ICH) (1994) Validation of analytical methods: Definitions and terminology ICH Q2 A
14. International Conference on Harmonization (ICH) (1996) Validation of analytical methods: Methodology ICH Q2 B
15. Vander-Heyden Y, Nijhuis A, Smeyers-Verbeke J, Vandeginste BG, Massart DL (2001) J Pharm Biomed Anal 24:723-753
16. Penninckx W, Hartmann C, Massart DL, Smeyers-Verbeke J (1996) J Anal At Spectrom 11:237-246
17. International Organization for Standardization (ISO) (1994) Accuracy (trueness and precision) of measurement methods and results: ISO/DIS 5725-1 to 5725-3. ISO, Geneva, Switzerland
18. NCCLS (1999) Evaluation of precision performance of clinical chemistry devices; Approved guideline. NCCLS, Wayne, Pa., USA
19. Toennes SW, Kauert GF (2001) J Anal Toxicol 25:339-343
20. EURACHEM/CITAC (2000) Quantifying uncertainty in analytical measurement http://www.eurachem.bam.de/guides/quam2.pdf