Application of confidence intervals to bioanalytical method validation and drug stability in biological matrix testing

Acta Poloniae Pharmaceutica - Drug Research

Volumn 65, Issue 6, 2008, Pages 743-747

  Rudzki, Piotr J ^a,b   Leś, Andrzej ^a  

^a INDUSTRIAL CHEMISTRY RESEARCH INSTITUTE   (Poland)

^b UNIVERSITY OF WARSAW   (Poland)

Author keywords

Bioanalysis; Confidence intervals; Pharmacokinetic studies; Stability; Statistics; Validation

Indexed keywords

GEMCITABINE; DEOXYCYTIDINE; DRUG DERIVATIVE;

ACCURACY; ANALYTIC METHOD; ARTICLE; BIOEQUIVALENCE; CALCULATION; CONFIDENCE INTERVAL; DRUG BIOAVAILABILITY; DRUG DETERMINATION; DRUG STABILITY; DRUG STORAGE; FOOD AND DRUG ADMINISTRATION; FREEZE THAWING; RELIABILITY; TECHNIQUE; VALIDATION PROCESS; ANIMAL; CHEMISTRY; FREEZING; HUMAN; METHODOLOGY; PHARMACOKINETICS; RAT; STATISTICAL ANALYSIS; VALIDATION STUDY;

ANIMALS; CHEMISTRY, PHARMACEUTICAL; CONFIDENCE INTERVALS; DATA INTERPRETATION, STATISTICAL; DEOXYCYTIDINE; DRUG STABILITY; FREEZING; HUMANS; PHARMACOKINETICS; RATS; VALIDATION STUDIES AS TOPIC;

EID: 61549115602     PISSN: 00016837     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (4)

1. Guidance for Industry: Bioanalytical Method Validation. U.S. Department of Health and Human Services. FDA. CDER. CVM. May 2001.
2. Timm U., Wall M., Dell D.: J. Pharm. Sci. 74, 972 (1985).
3. nd Ed., Marcel Dekker, Inc., New York and Basel 1990.
4. SAS ver. 9.1, SAS Institute Inc., Cary, NC, U.S.A.