A greater understanding of the nature of LAL-Test interferences and the use of permissible
dilution have minimized inhibition problems. Common interference mechanisms include …

The limulus amebocyte lysate (LAL) test is the simplest and most widely used procedure for
detection of endotoxin in parenteral drugs. The LAL test demands optimal pH, ionic strength …

Data presented in this study indicate that there is considerable variability in spike recoveries
between th~ ee different_ kinetic LAL methods as used for the testing of a variety of …

ABSTRACT A program in BASIC which computes LD50 and related parameters is
presented. The program is an implementation of Finney's maximum likelihood probit …

The measurement of low levels of bacterial lipopolysaccharides (endotoxins) in protein
samples can be a challenge due to potential interference from the inherent properties of the …

Development of robust, accurate, precise, and linear assays is at the heart of development
activities for drug product and drug substances. Determining the limits of what an assay can …

Many regulatory standards and guidelines require LD50 determinations and dose-response
curve slopes, using at least 5 animals per sex per dosage level and at least 3 levels. In …

Sensitive and specific methodology is required for the detection and characterization of anti-
drug antibodies (ADAs). High-quality ADA data enables the evaluation of potential impact of …

One of the major professional responsibilities of clinical scientists who work in hospital
laboratories is the explanation of unexpected, misleading, or apparently erroneous results of …

The interpretation of clinical laboratory tests is dependent on a host of physiological,
environmental and pharmacological factors. At present, it is difficult to determine which of …