Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Are photocopies of raw data, which are dated and verified by signature of the copier, considered to be “exact” copies of the raw data? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans Are animal cage cards considered to be raw data? 1.32K viewsDrugsPharmaceutical 0 Votes 1 Ans Are subcontractor laboratories that furnish a particular service such as ophthalmology exams, reading of animal ECGs, EEGs, EMGs, preparation of blocks and slides from tissues, statistical analysis and hematology covered by the GLPs? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it possible to obtain an exemption from specific provisions of the GLPs for special nonclinical laboratory studies? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the GLPs apply to all of the analytical support work conducted to provide supplementary data to a safety study? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the GLPs apply to safety studies on cosmetic products? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans Do safety studies done to determine the potential drug-abuse characteristics of a test article have to be done under the GLPs? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the GLPs apply to validation trials conducted to confirm the analytical methods used to determine the concentration of test article in animal tissues and drug dosage forms? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Must a sponsor reveal toxicology data already collected on a test article to a contract laboratory? 1.45K viewsDrugsPharmaceutical 0 Votes 1 Ans Must a contractor include in the final report information on test article characterization and stability when such information has been collected by the sponsor? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans Do contract laboratories have to show the sponsor’s name on the Master Schedule Sheet or can this information be coded? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans Who is responsible for test article characterization – the sponsor or the contractor? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans A firm functions as a primary contractor for nonclinical laboratory studies. The actual studies are then subcontracted to nonclinical laboratories. Is the firm considered to be a “sponsor?” 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the GLPs require that a sponsor approve the study director for a contracted study? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans Necropsies are done by prosecutors trained by and working under the supervision of a pathologist. The necropsy data are recorded by the prosecutor on data sheets, and when making the final report, the pathologist summarizes the data collected by the prosecutor as well as by him/herself. What constitutes the raw data in this example? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans The definition of “nonclinical laboratory study” excludes field trials in animals. What is a field trial in animals? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans A laboratory conducts animal studies to establish a baseline set of data for a different test species/strain. No test article is administered but the toxicology laboratory facilities and procedures will be used and the resulting data may eventually be submitted do the agency as part of a research or marketing permit. Are the studies considered to be nonclinical laboratory studies that are covered by the GLPs? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans How long does FDA allow a laboratory to effect corrective actions after an inspection has been made? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans What background materials are used by agency investigators to prepare for a GLP inspection? 1.67K viewsDrugsPharmaceutical 0 Votes 1 Ans Does FDA inspect international nonclinical laboratories once every two years? 1.54K viewsDrugsPharmaceutical « Previous 1 2 … 15 16 17 18 19 … 79 80 Next » Question and answer is powered by anspress.net
