Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 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? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the GLPs require specific procedures for the microbiological monitoring of animals used in nonclinical laboratory studies? 1.34K 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? 1.56K 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? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans Does each nonclinical laboratory study require a sponsor-approved specific protocol? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans Must an analytical method be totally contained in the protocol? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the proposed starting and completion dates for a nonclinical laboratory study? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans The analysis of test article mixtures that are used in acute studies is problematic. Usually at the stage of product development, the analytical method is not fully developed. Also, getting the analytical department to schedule the analysis is difficult. Stability is not a problem since fresh solutions are used. In view of the fact that acute studies are not pivotal in gaining approval of a research or marketing permit, is it necessary to analyze test article mixtures? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans Do homogeneity studies need to be done on solutions and suspensions of test articles used in acute nonclinical laboratory studies? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans For liquid dosing studies where the test article mixture is made by dilution of the highest dose, which dose should be analyzed? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans For acute studies, does the test article carrier mixture have to be analyzed (single dose studies)? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the purpose of periodic analysis requirement for test or control article mixtures? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans Do test or control article concentration assays have to be performed on each batch of test or control article carrier mixture? 1.44K viewsDrugsPharmaceutical 0 Votes 1 Ans Who approves the final report of a nonclinical laboratory study? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans Do all circumstances that may have affected the quality of the data have to be described in the final report? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans Does Section 58:115(a) describe the format for submission of a final report? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans Do contributing scientist’s reports have to be prepared and appended to final reports or can the contributing scientist’s report be included in the final report prepared by the study director and signed by each contributing scientist? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to manually transcribe raw data into notebooks if it is verified accurate by signature and date? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans Is a positive notation (a statement of what was done in the raw data) required for routine laboratory operations such as: a. identifying animals, b. shaving or abrading rabbits, c. specific dosing procedures, and d. fasting of animals? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans Do tissue slides have to carry the complete sample labeling information stated in the GLPs? 1.28K viewsDrugsPharmaceutical « Previous 1 2 … 19 20 21 22 23 … 82 83 Next » Question and answer is powered by anspress.net
