Is saliva suitable as a biological fluid in relative bioavailability studies? Analysis of its performance in a 4 × 2 replicate crossover design

European Journal of Drug Metabolism and Pharmacokinetics

Volumn 36, Issue 4, 2011, Pages 229-236

  Ruiz, M Esperanza ^a   Fagiolino, Pietro ^b   De Buschiazzo, Perla M ^c   Volonté, M Guillermina ^a  

^a FACULTAD DE CIENCIAS EXACTAS   (Argentina)

^b UNIVERSIDAD DE LA REPÚBLICA   (Uruguay)

^c UNIVERSIDAD NACIONAL DE LA PLATA   (Argentina)

Author keywords

Individual bioequivalence; Phenytoin; Relative bioavailability; Saliva

Indexed keywords

PHENYTOIN;

ABSENCE OF SIDE EFFECTS; ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG HALF LIFE; DRUG RELEASE; FEMALE; HUMAN; HUMAN EXPERIMENT; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; SALIVA ANALYSIS; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADULT; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; CROSS-OVER STUDIES; FEMALE; HUMANS; MALE; PHENYTOIN; SALIVA; THERAPEUTIC EQUIVALENCY;

EID: 84856260952     PISSN: 03787966     EISSN: 21070180     Source Type: Journal    
DOI: 10.1007/s13318-011-0051-z     Document Type: Article

References (29)

1. Anderson GD (2008) Understanding the ramifications of switching among AEDS: what are the data? Adv Stud Pharm 5(5):146-151
2. Anderson S, Hauck WW (1990) Consideration of individual bioequivalence. J Pharmacokinet Biopharm 18(3):259-273 (Pubitemid 20308933)
3. Anderson S, Hauck WW (1996) The transitivity of bioequivalence testing: potential for drift. Int J Clin Pharmacol Ther 34(9): 369-374 (Pubitemid 26305808)
4. ANMAT. Especialidades Medicinales, Disposición 5318/2002 (available at http://www.anmat.gov.ar/webanmat/Legislacion/Medicamentos/ Disposicion-ANMAT-5318-2002.pdf). Accessed 7November 2002
5. Armijo JA, Herranz JL (2003) Fármacos antiepilépticos y anticonvulsivos. In: Masson (ed) Farmacología Humana - J. Flórez. Barcelona, pp 517-541
6. Benet LZ (1999) Understanding bioequivalence testing. Transplantation Proc 31 (3, Suppl 1):7S-9S (Pubitemid 29228390)
7. Benet LZ, Goyan JE (1995) Bioequivalence and narrow therapeutic index drugs. Pharmacotherapy 15(4):433-440
8. Christians U, First MR, Benet LZ (2000) Recommendations for bioequivalence testing of cyclosporine generics revisited. Ther Drug Monit 22(3):330-345 (Pubitemid 30346452)
9. Drobitch RK, Svensson CK (1992) Therapeutic drug monitoring in saliva. An update. Clin Pharmacokinet 23(5):365-379
10. EMEA/CPMP (2001) Note for guidance on the investigation of bioavailability and bioequivalence
11. EMEA/CPMP (2002) Note for guidance on good clinical practice (CPMP/ICH/135/95)
12. Endrenyi L, Midha KK (1998) Individual bioequivalence-has its time come? Eur J Pharm Sci 6(4):271-277 (Pubitemid 28468534)
13. Fagiolino P (1999) Monitorizacion de farmacos en saliva: aplicaciones biofarmaceuticas, farmacocineticas y terapeuticas. 1a edn. Comision Sectorial de Investigacion Cientifica (CSIC) de la Universidad de la Republica, Montevideo, Urugua
14. FDA/CDER (2001a) Guidance for industry: bioanalytical method validation
15. FDA/CDER (2001b) Guidance for industry: statistical approaches to establishing bioequivalence
16. FDA/CDER (2003) Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products-general considerations
17. Goodman LS, Gilman A (2006) Goodman and Gilman's the pharmacological basis of therapeutics, 11th edn. McGraw-Hill, Medical Publishing Division, New York
18. Joukhadar C, Schenk B, Kaehler ST, Kollenz CJ, Bauer P, Muller M, Eichler HG (2003) A replicate study design for testing bioequivalence: a case study on two desmopressin nasal spray preparations. Eur J Clin Pharmacol 59(8-9):631-636 (Pubitemid 37494531)
19. Melikian AP, Straughn AB, Slywka GW, Whyatt PL, Meyer MC (1977) Bioavailability of 11 phenytoin products. J Pharmacokinet Biopharm 5(2):133-146 (Pubitemid 8128157)
20. Midha KK, Rawson MJ, Hubbard JW (1998) Bioequivalence: switchability and scaling. Eur J Pharma Sci 6(2):87-91 (Pubitemid 28164277)
21. Moffat AC, Widdop B, Osselton MD, Clarke EGC (2004) Clarke's analysis of drugs and poisons: in pharmaceuticals, body fluids and postmortem material, 3rd edn. Pharmaceutical Press, London
22. Posti J (1982) Saliva-plasma drug concentration ratios during absorption: theoretical considerations and pharmacokinetic implications. Pharm Acta Helv 57(3):83-92
23. Ritschel WA, Tompson GA (1983) Monitoring of drug concentrations in saliva: a non-invasive pharmacokinetic procedure. Methods Find Exp Clin Pharmacol 5(8):511-525 (Pubitemid 14176731)
24. Ruiz ME, Conforti P, Fagiolino P, Volonté MG (2010) The use of saliva as a biological fluid in relative bioavailability studies: comparison and correlation with plasma results. Biopharm Drug Dispos 31:476-485
25. Schall R, Williams RL (1996) Towards a practical strategy for assessing individual bioequivalence. Food and drug administration individual bioequivalence working group. J Pharmacokinet Biopharm 24(1):133-149
26. Schumaker R, Metzler C (1998) The phenytoin trial is a case study of individual bioequivalence. Drug Inf J 32:1063-1072 (Pubitemid 28531395)
27. Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, Yacobi A, Layloff T, Viswanathan CT, Cook CE, McDowall RD et al (1991) Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Conference report. Eur J Drug Metab Pharmacokinet 16(4):249-2551
28. World Medical Association Declaration of Helsinki (2004) Ethical principles for medical research involving human subjects. J Int Bioethique 15(1):124-129
29. Yacobi A, Masson E, Moros D, Ganes D, Lapointe C, Abolfathi Z, LeBel M, Golander Y, Doepner D, Blumberg T, Cohen Y, Levitt B (2000) Who needs individual bioequivalence studies for narrow therapeutic index drugs? A case for warfarin. J Clin Pharmacol 40(8):826-835