Assessing parallelism prior to determining relative potency

PDA Journal of Pharmaceutical Science and Technology

Volumn 59, Issue 2, 2005, Pages 127-137

  Hauck, Walter W ^a   Capen, Robert C ^b   Callahan, Janice D ^c   De Muth, James E ^d   Hsu, Henry ^e   Lansky, David ^f   Sajjadi, Nancy C ^g   Seaver, Sally S ^h   Singer, Robert R ⁱ   Weisman, Doris ^j  

^a THOMAS JEFFERSON UNIVERSITY   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

^c Callahan Associates Inc   (United States)

^d UNIVERSITY OF WISCONSIN MADISON   (United States)

^e CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^f Lansky Consulting   (United States)

^g Sajjadi Associates Inc   (United States)

^h Seaver Associates   (United States)

ⁱ PROTEIN DESIGN LABS INC   (United States)

^j ELI LILLY AND COMPANY   (United States)

more..

Author keywords

Bioassay; Hypothesis testing; Parallelism; Similarity

Indexed keywords

DRUG;

ACCURACY; ARTICLE; BIOASSAY; CONFIDENCE INTERVAL; DRUG DETERMINATION; DRUG POTENCY; EUROPE; HYPOTHESIS; LABORATORY; MEDICAL LITERATURE; STATISTICAL ANALYSIS; UNITED STATES;

DATA INTERPRETATION, STATISTICAL; PHARMACEUTICAL PREPARATIONS; PHARMACOPOEIAS; REPRODUCIBILITY OF RESULTS; TECHNOLOGY, PHARMACEUTICAL; THERAPEUTIC EQUIVALENCY;

EID: 25144434307     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (7)

1. rd ed.; Charles Griffin: London, 1978.
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4. Klein, J.; Capen, R.; Mancinelli, R.; Robinett, R.; Pietrobon, P.J.F.; Quinn, J.; Schofield, T. Validation of Assays for Use with Combination Vaccines. Biologicals 1999, 27, 35-41.
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6. Plikaytis, B.D.; Holder, P.F.; Pais, L.B.; Maslanka, S.E.; Gheeling, L.L.; Carlone, G.M. Determination of parallelism and nonparallelism in bioassay dilution curves. J. Clin. Microbiol. 1994, 32, 2441-7.
7. Hahn, G.J.; Meeker, W.Q. Statistical Intervals: A Guide for Practitioners; Wiley: New York, 1991.