SUMMARYA validation protocol for multicomponent spectroscopic assays based on principal components regression is described. Factorial design and hypothesis tests are used to establish the linearity and absence of interaction between components in the regression model. Testing considers multiple response variables simultaneously so that correlation between residuals is properly treated. Assay reproducibility and sensitivity to related substances are evaluated.
This review provides a comprehensive list of in vivo and in vitro studies that have investigated alcohol induced dose dumping (AIDD) in modified release dosage forms. Of the numerous classes of drugs commercially available as modified release products, opioids, centrally acting drugs, and drugs with a narrow therapeutic index present high risks from dose dumping, despite being formulated in a manner that releases drug in a tailored or delayed fashion. Awareness of AIDD has led to the withdrawal of a few marketed products by Regulatory Agencies, and black box warnings on others. Since then, significant effort has focused on proving the robustness of a formulation when co-ingested with alcohol. Patient risk is deemed to be low if the formulation and its performance is unimpaired by the presence of 0-40% alcohol under in vivo and in vitro conditions.
A general purpose interactive programmable laboratory interface system using the IEEE488 Bus Comput. Phys. 5, 323 (1991); 10.1063/1.168411Laboratory demonstrations through the use of a general purpose correlator Am.The instrument described here was designed as a laboratory aid for the visually handicapped. It is basically a 3 1!2-digit multimeter with speech output; however, it has added functions which extend its usefulness beyond the ability to measure the usual ranges of ac and dc voltage and current. The device can function as a thermometer, a pH meter, a 6-digit timer, and an events counter. Two voltage-to-frequency (V IF) converters make it useful as an audible comparator and peak detector. An integrator is realized by using the counter to count the pulse train from a V IF converter which monitors the input signal. A low-level differential channel is provided for interfacing to instruments with recorder outputs, such as gas chromatographs. Spoken values of measured quantities are accompanied by sign, decimal point, and units. The instrument can also interface with other digital devices through 42 lines of parallel digital input-output. It can convert seven parallel BCD digits into speech or it can output BCD data from its counter or converter to a microcomputer.
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