Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans What are the GLP requirements that are applicable to computerized data – acquisition systems? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans Does raw data collected in nonclinical laboratory studies have to be cosigned by a second individual? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans Who assesses protocol validity (Number of animals, test article dosage, test system, etc.)? 1.49K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the GLPs require that absorption studies be done on each test article? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the protocol have to list the SOPS used in a specific study? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans Certain raw data records are not study specific (pest control, instrument calibration). Must these be filed in the archives in each study file? 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans How does the agency view interim reports of nonclinical laboratory studies? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans How are protocol deviations, which are discovered after the completion of the study to be handled? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the phase of the study, which has been inspected, need to be identified in the QAU statement in the final report? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans Does everyone who participated in a study have to be identified in the final report? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans Can the chemistry information required by Section 58.185(a)(4) be located elsewhere in the application for a research or marketing permit? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans If animals used in acute studies are subjected to necropsy, is it necessary to retain the organs as study specimens 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans For a GLP regulated metabolism study, whole tissues are homogenized and aliquots thereof are used for analysis. Is it necessary to retain all of the remaining homogenate as a reserve sample? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans With regard to blood and urine specimens, which are analyzed for both labile and stable constituents, is it necessary to retain the specimen until the most stable constituent deteriorates? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans Can a study director or a pathologist be responsible for storing and retaining specimens and raw data? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans At the termination of a nonclinical laboratory study, can a contractor send all of the raw data, study records, and specimens to the sponsor of the study? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Where should the QAU records be retained? 1.67K viewsDrugsPharmaceutical 0 Votes 1 Ans What should be done about nonclinical laboratory studies that are stopped prior to completion? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans Does FDA reject nonclinical laboratory studies that have not been conducted in full compliance with the GLPs? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans Is a specific conforming amendment statement as required by Part 314(f)(7) to be prepared for each nonclinical laboratory study? 1.52K viewsDrugsPharmaceutical « Previous 1 2 … 87 88 89 90 91 … 283 284 Next » Question and answer is powered by anspress.net
