Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Do the procedures used for preparing the S9 activator fraction (liver microsomal challenge to be performed in accord with the GLPs? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans How extensive should the procedures be for confirming the quality of incoming reagents used in nonclinical laboratory studies? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the GLP requirements for labeling of reagents purchased directly from manufacturers? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans To what extent are computer programs to be documented as SOPS? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the GLPs require tests for homogeneity, concentration, and stability on mixtures of control articles used as positive controls? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans With regard to safety studies in large animals (cattle, horses, etc.), must test article accountability be maintained and can the animals be used-for food purposes? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans Are physical and chemical tests conducted on test articles required to be done under the GLPs? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans If analysis of the reserve samples is required by the Study Director or the QAU, is it permitted? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans What expiration date is placed on the label of test articles whose stability is being assessed concurrently with the conduct of the study? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to retain samples of feed from nonclinical laboratory studies in which the feed serves as the control article? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans Is a separate room required for animal necropsy? 1.34K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the GLPs require production facilities to be dedicated to the manufacture of specific animal feeds used in nonclinical laboratory studies? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans It is necessary to use “official” methods of analysis to determine the levels of interfering contaminants? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the frequency of feed contaminant analysis? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans The Japanese are preparing animal care guidelines, which are similar but not identical to the U.S. guidelines prepared by NIH. Would these be acceptable? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the GLPs require specific procedures for the microbiological monitoring of animals used in nonclinical laboratory studies? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans Pathologists at a firm would like to take tissues from animals in a nonclinical study, which would be used to conduct exploratory research studies. The tissues would not be part of the nonclinical laboratory study design and the results would not necessarily pertain to the study objectives. What would the GLPs require in this case? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans Do unforeseen circumstances which occur during a study and which necessitate minor operational changes have to be reported as protocol amendments? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans Does each nonclinical laboratory study require a sponsor-approved specific protocol? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans Must an analytical method be totally contained in the protocol? 1.50K viewsDrugsPharmaceutical « Previous 1 2 … 18 19 20 21 22 … 79 80 Next » Question and answer is powered by anspress.net
