Can computer simulations replace clinical pharmacokinetic studies? The In-silico-Child;Können computer-simulationen klinisch-pharmakokinetische studien ersetzen? Das In-silico-Child

Pharmazie in Unserer Zeit

Volumn 38, Issue 1, 2009, Pages 62-67

  Willmann, Stefan ^a  

^a BAYER AG   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD SAMPLING; CHILD; CLINICAL STUDY; COMPUTER MODEL; COMPUTER SIMULATION; DOSE CALCULATION; DRUG INDUSTRY; HUMAN; INTENSIVE CARE UNIT; METHODOLOGY; PEDIATRICS; PHARMACOKINETICS; SHORT SURVEY; METABOLISM; REVIEW;

DRUG;

CHILD; COMPUTER SIMULATION; HUMANS; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS;

EID: 59349092572     PISSN: 00483664     EISSN: 16151003     Source Type: Journal    
DOI: 10.1002/pauz.200800297     Document Type: Short Survey

References (10)

1. Pandolfini, C., Bonati, M.: A literature review on off-label drug use in children. Eur. J. Pediatr. 164 (2005), 552-558.
2. Cuzzolin, L., Atzei, A., Fanos, V.: Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety. Expert Opin. Drug Saf. 5 (2006), 703-718.
3. FDA: Best Pharmaceuticals for Children Act. Pub L No. 107-109 (2002) (http://www.fda.gov/opacom/laws/pharmkids/contents.html).
4. EMEA: Better Medicines for Children (http://www.emea.europa.eu/htms/ human/paediatrics/introduction.htm).
5. Verordnung (EG) Nr. 1901/2006 des Europäischen Parlaments und des Rates vom 12. Dezember 2006 über Kinderarzneimittel. (2006) (http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/reg-2006-1901/ reg-2006-1901-de.pdf).
6. Nestorov, I.: Whole-body physiologically based pharmacokinetic models. Expert Opin. Drug Metab. Toxicol. 3 (2007), 235-249.
7. Edginton, A.N., Theil, F.-P., Schmitt, W., Willmann, S.: Whole body physiologically-based pharmacokinetic models: their use in clinical drug development. Expert Opin. Drug Metab. Toxicol. 4 (2008), 1143-1152.
8. Willmann, S., Lippert, J., Sevestre, M., Solodenko, J., Fois, F., Schmitt, W.: PK-Sim®: a physiologically based pharmacokinetic 'whole-body' model. Biosilico 1 (2003), 121-124.
9. Edginton, A.N., Schmitt, W., Willmann, S.: Development and evaluation of a generic physiologically based pharmacokinetic model for children. Clin. Pharmacokinet. 45 (2006), 1013-1034.
10. Edginton, A.N., Schmitt, W., Voith, B., Willmann, S.: A mechanistic approach for the scaling of clearance in children. Clin. Pharmacokinet. 45 (2006), 683-704.