The role of population pharmacokinetics in drug development in light of the Food and Drug Administration's 'Guidance for Industry: Population Pharmacokinetics'

Clinical Pharmacokinetics

Volumn 39, Issue 6, 2000, Pages 385-395

  Williams, P J ^a,b   Ette, E I ^c  

^a UNIVERSITY OF THE PACIFIC   (United States)

^b Trials by Design   (United States)

^c VERTEX PHARMACEUTICALS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALPRAZOLAM; DOCETAXEL; IMIPRAMINE;

AREA UNDER THE CURVE; CLINICAL TRIAL; DRUG INDUSTRY; DRUG INHIBITION; DRUG LABELING; DRUG MONITORING; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMATION PROCESSING; LUNG NON SMALL CELL CANCER; NONHUMAN; PLANNING; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; RISK BENEFIT ANALYSIS; SIMULATION; STAFF TRAINING; TOXICOKINETICS; VALIDATION PROCESS;

EID: 0034493124     PISSN: 03125963     EISSN: None     Source Type: Journal    
DOI: 10.2165/00003088-200039060-00001     Document Type: Review

References (45)

1. Estimation of population characteristics of pharmacokinetic parameters from routine clinical data
2. Role of population pharmacokinetics in drug development a pharmaceutical industry perspective
3. Impact of population pharmacokinetic-pharmacodynamic analyses on the drug development process
4. The population approach: FDA experience
5. Population pharmacokinetics: A regulatory perspective
6. Population pharmacokinetic modeling: The importance of informative graphics
7. Application of modern statistical techniques to the process of knowledge discovery from large pharmacokinefic data sets
8. Population approach in drug development: Rational and basic concepts
9. Learning versus confirming in clinical drug development
10. A population pharmacokinetic model for docetaxel (taxotere): Model building and validation
11. Predicting effective drug concentrations for individual patients: Determinants of pharmacodynamic variability
12. Pharmacodynamic modeling of the electroencephalographic effects of flumazenil in healthy volunteers sedated with midazolam
13. Pharmacokinetic pharmacodynamic modelling of oxprenolol in man using continuous non-invasive blood pressure monitoring
14. Blood disoprofol levels in anaesthetized patients
15. Pharmacodynamic variability of flecainide assessed by QRS changes
16. Population pharmacokinetics/pharmacodynamics of docetaxel in phase II studies in patients with cancer
17. From data mining to knowledge discovery: An overview
18. Mixed effect modeling of sumatriptan pharmacokinetics during drug development. I: Interspecies allometric scaling
19. Sparse sampling for assessment of drug exposure in toxicological studies
20. Sparse-sampling optimal designs in pharmacokinetics and toxicokinetics
21. Commentary on 'Physiologically based pharmacokinetic modeling as a tool for drug development'
22. Application of population analysis to physiological pharmacokinetics
23. Physiologically based pharmacokinetic modeling as a tool for drug development
24. Physiologically based pharmacokinetics of cyclosporin A: Extension to tissue distribution kinetics in rats and scale-up to humans
25. Good pharmacokinetic practice (GPP) and logistics: A continuing challenge
26. An automated drug concentration screening and quality assurance program for clinical trials
27. Design of popularion pharmacokinetic studies
28. Designing cross-sectional pharmacokinetic studies: Implications for pediatric and animal studies
29. Ignorability and parameter estimation in longitudinal pharmacokinetic studies
30. Balanced designs in longitudinal population pharmacokinetic studies
31. Comparison of some practical sampling strategies for population pharmacokinetic studies
32. Analysis of animal pharmacokinetic data: Performance of the one point per animal design
33. The importance of modeling inter-occasion variability in population pharmacokinetic analyses
34. Detection of influential observation in linear regression
35. Multiple imputation after 18+ years
36. Stability and performance of a population pharmacokinetic model
37. Direct comparison of three methods for predicting digoxin concentrations
38. Posterior predictive assessment of model fitness via realized discrepancies
39. Validation of population pharmacokinetic/pharmacodynamic analyses: Review of proposed approaches
40. 5-Fluorocytosine: Population pharmacokinetic model development, nonparametric bootstrap validation and dosing strategy evaluation
41. Docetaxel
42. An evaluation of population pharmacokinetics in therapeutic trials. Pt II: Detection of a drug-drug interaction
43. CYP2C19 polymorphism effect on phenobarbitone pharmacokinetics in Japanese patients with epilepsy: Analysis by population pharmacokinetics