A guide for reporting the results of population pharmacokinetic analyses: A Swedish perspective

AAPS Journal

Volumn 7, Issue 2, 2005, Pages

  Wade, Janet R ^a   Edholm, Monica ^b   Salmonson, Tomas ^b  

^a Exprimo NV   (Sweden)

^b MEDICAL PRODUCTS AGENCY   (Sweden)

Author keywords

NONMEM; Population analysis reports; Regulatory aspects

Indexed keywords

CASPOFUNGIN; ENFUVIRTIDE; FONDAPARINUX;

AGE; ARTICLE; COLOR; COVARIANCE; DATA ANALYSIS; DATA ANALYSIS SOFTWARE; DECISION SUPPORT SYSTEM; DRUG INFORMATION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; KIDNEY DYSFUNCTION; MANDATORY REPORTING; PHARMACOLOGICAL PROCEDURES; PLOTS AND CURVES; POPULATION RESEARCH; PROCESS DEVELOPMENT; PROCESS MODEL; SIMULATION; SWEDEN; BIOLOGICAL MODEL; PHARMACOKINETICS; PRACTICE GUIDELINE; REVIEW; STANDARD;

GUIDELINES; HUMANS; MODELS, BIOLOGICAL; PHARMACOKINETICS; SWEDEN;

EID: 30444450823     PISSN: 15221059     EISSN: 15221059     Source Type: Journal    
DOI: 10.1208/aapsj070245     Document Type: Article

References (4)

1. Beal S, Sheiner L, eds. NONMEM Users Guides. NOMMEM Project Group, San Francisco: University of California at San Francisco; 1998.
2. Wählby U, Jonsson EN, Karlsson MO. Assessment of actual significance levels for covariate effects in NONMEM. J Pharmacokinet Pharmacodyn. 2001;28:231-252.
3. Ribbing J, Jonsson EN. Power, selection bias and predictive performance of the population pharmacokinetic covariate model. J Pharmacokinet Pharmacodyn. 2004;31:109-134.
4. CPMP/EWP/560/95. Note for Guidance on the Investigation of Drug Interactions (CPMP adopted Dec. 97).