Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 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 0 Votes 1 Ans In Japan, employees do not sign raw data records but rather they use an official seal, which is unique to the employee. Is this an acceptable procedure? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the GLP requirements that are applicable to computerized data – acquisition systems? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans Does raw data collected in nonclinical laboratory studies have to be cosigned by a second individual? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans Who assesses protocol validity (Number of animals, test article dosage, test system, etc.)? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the GLPs require that absorption studies be done on each test article? 1.33K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the protocol have to list the SOPS used in a specific study? 1.36K viewsDrugsPharmaceutical « Previous 1 2 … 19 20 21 22 23 … 79 80 Next » Question and answer is powered by anspress.net
