Model-based evaluation of similarity in pharmacokinetics of two formulations of the blood-derived plasma product C1 esterase inhibitor

Journal of Clinical Pharmacology

Volumn 52, Issue 2, 2012, Pages 204-213

  Keizer, Ron J ^a   Budde, Ilona Kleine ^b   Sprengers, Paul F W ^b   Levi, M ^c   Beijnen, Jos H ^a,d   Huitema, Alwin D R ^a  

^a NETHERLANDS CANCER INSTITUTE   (Netherlands)

^b Sanquin Plasmaproducten   (Netherlands)

^c UTRECHT UNIVERSITY   (Netherlands)

^d UNIVERSITY OF AMSTERDAM   (Netherlands)

Author keywords

Biosimilarity; C1 esterase inhibitor; modeling; pharmacokinetics; simulation

Indexed keywords

CETOR; COMPLEMENT COMPONENT C1S; COMPLEMENT COMPONENT C1S INHIBITOR; UNCLASSIFIED DRUG;

ANGIONEUROTIC EDEMA; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL ARTICLE; CONTROLLED STUDY; DRUG FORMULATION; DRUG HALF LIFE; HUMAN; BIOLOGICAL MODEL; CHEMISTRY; COMPUTER SIMULATION; CROSSOVER PROCEDURE; PLASMA; RANDOMIZED CONTROLLED TRIAL; THERAPEUTIC EQUIVALENCE;

COMPLEMENT C1 INHIBITOR PROTEIN; COMPUTER SIMULATION; CROSS-OVER STUDIES; HUMANS; MODELS, BIOLOGICAL; PLASMA; THERAPEUTIC EQUIVALENCY;

EID: 84856599799     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270010394446     Document Type: Article

References (14)

1. FDA/CDER guidance for industry: bioavailability and bioequivalence studies for orally administered drug products-general considerations. 2003. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm070124.pdf. Accessed October 5, 2007.
2. EMEA/CHMP guideline on the investigation of bioequivalence. 2009. http://www.emea.europa.eu/pdfs/human/qwp/140198enrev1.pdf. Accessed January 26, 2010.
3. EMEA/CPMP note for guidance on plasma-derived medicinal products. 2001. http://www.ema.europa.eu/pdfs/human/bwp/026995en.pdf. Accessed January 26, 2010.
4. Hu C, Sale M Pharmacometrics: The Science of Quantitative Pharmacology. 1 st ed.Hoboken, NJ: Wiley Interscience; 2007: 421-453. Ette EI Williams PJ, ed. Hoboken, NJ: Wiley Interscience ; 2007: 421-453.
5. Kaniwa N, Aoyagi N, Ogata H, Ishii M. Application of the NONMEM method to evaluation of the bioavailability of drug products. J Pharm Sci. 1990 ; 79: 1116-1120
6. Maier GA, Lockwood GF, Oppermann JA, et al. Characterization of the highly variable bioavailability of tiludronate in normal volunteers using population pharmacokinetic methodologies. Eur J Drug Metab Pharmacokinet. 1999 ; 24: 249-254 (Pubitemid 30077014)
7. Pentikis HS, Henderson JD, Tran NL, Ludden TM. Bioequivalence: individual and population compartmental modeling compared to the noncompartmental approach. Pharm Res. 1996 ; 13: 1116-1121 (Pubitemid 26259017)
8. Hu C, Moore KHP, Kim YH, Sale ME. Statistical issues in a modeling approach to assessing bioequivalence or PK similarity with presence of sparsely sampled subjects. J Pharmacokinet Pharmacodyn. 2004 ; 31: 321-339 (Pubitemid 39287339)
9. Beal SL, Sheiner L. NONMEM Users Guides. Ellicott City, Md: Icon Development Solutions; 1989.
10. EMEA/CPMP note for guidance on the clinical investigation of plasma derived antithrombin products. 2002. http://www.ema.europa.eu/pdfs/human/bwp/ 026995en.pdf. Accessed January 26, 2010.
11. Dansirikul C, Silber H, Karlsson M. Approaches to handling pharmacodynamic baseline responses. J Pharmacokinet Pharmacodyn. 2008 ; 35: 269-283
12. US FDA. Office of the Commissioner challenges and opportunities report-March 2004. http://www.fda.gov/ScienceResearch/SpecialTopics/ CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htm. Accessed January 26, 2010.
13. FDA Guidance for industry: population pharmacokinetics. 1999. http://www.fda.gov/cder/guidance/index.htm. Accessed January 26, 2010.
14. Guideline on Reporting the Results of Population Pharmacokinetic Analyses. London, UK: EMEA ; 2008: