An evaluation of the integration of pharmacokinetic and pharmacodynamic principles in clinical drug development. Experience with Hoffmann La Roche

Clinical Pharmacokinetics

Volumn 33, Issue 2, 1997, Pages 142-152

  Reigner, Bruno G ^a   Williams, Peter E O ^a   Patel, Indra H ^b   Steimer, Jean Louis ^a   Peck, Carl ^c   Van Brummelen, Peter ^d  

^a F HOFFMANN LA ROCHE LTD   (Switzerland)

^b HOFFMANN LA ROCHE INC   (United States)

^c GEORGETOWN UNIVERSITY   (United States)

^d Solvay Human Health Division   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

CLINICAL PHARMACOLOGY; HUMAN; PHARMACODYNAMICS; PRIORITY JOURNAL; REVIEW;

EID: 0030849120     PISSN: 03125963     EISSN: None     Source Type: Journal    
DOI: 10.2165/00003088-199733020-00005     Document Type: Review

References (9)

1. Peck CC, Burr WH, Benet LZ, et al. Opportunities for integration of pharmacokinetics, pharmucodynamics and toxicokinetics in rational drug development. Clin Pharmacol Ther 1992; 51: 465-73
2. Peck CC. Rationale tor the effective use of pharmacokinetics und pharmacodynamics in early drug development, In: Yacohi A, Skelly JP, Shah VP, et al. editors, Integration of pharmaL'okinetics, pharmucodynamics and tuxicokinetics in rational drug development, New York: Plenum Press, 1995: 1-5
3. Holford NHG, Peck CC. Population pharmacodynamics and drug development. In: van Boxtel CJ, Holford NHG, Dunhof M, editors, The in vivo study of drug action. New York: Elsevier Science. 1992:401-13
4. Camphell DB. The use of kinetic-dynamic interactions in the evaluation of drugs. Psychopharmacology 1991; 100: 438-30
5. Sale ME, Blaschke TF. Incorporating pharmacokinetic/pharmacodynamic modeling in drug development: are we ready? Drug Inf J 1992; 26: 119-24
6. International Conference on Hurmonization. Harmonized tripartite guideline on dose response information to support drug registration. Geneva: ICH Secretariat, 1995
7. Holford NHG. The target concentration approach to clinical drug development. Clin Pharmacokinel 1995; 29: 287-91
8. Lemmens HJM, Dyck JB, Schafer SL, et al. Pharmacokineticpharmacodynamic modeling in drug development: application to the investigational opioid trefentanil. Clin Pharmacol Ther 1994; 56: 261-71
9. Sieimer JL, Kawai S, Charnick S, et al. Physiological pharmacokinetic/pharmacodynamic (PB-PK/PD) models in drug development? In: Danhof M, Peck C, editors. Advances in simultancous pharmacokinetic/pharmacodynamic modelling. Leiden: Leiden University.,1994: 42-7