Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 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? 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the GLP requirements that are applicable to computerized data – acquisition systems? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans Does raw data collected in nonclinical laboratory studies have to be cosigned by a second individual? 1.36K viewsDrugsPharmaceutical 0 Votes 1 Ans Who assesses protocol validity (Number of animals, test article dosage, test system, etc.)? 1.26K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the GLPs require that absorption studies be done on each test article? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the protocol have to list the SOPS used in a specific study? 1.43K 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? 946 viewsDrugsPharmaceutical 0 Votes 1 Ans How does the agency view interim reports of nonclinical laboratory studies? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans How are protocol deviations, which are discovered after the completion of the study to be handled? 1.13K 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? 1.36K viewsDrugsPharmaceutical 0 Votes 1 Ans Does everyone who participated in a study have to be identified in the final report? 1.30K 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? 1.06K 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 1.26K 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? 1.23K 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? 1.33K viewsDrugsPharmaceutical 0 Votes 1 Ans Can a study director or a pathologist be responsible for storing and retaining specimens and raw data? 1.31K 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? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans Where should the QAU records be retained? 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans What should be done about nonclinical laboratory studies that are stopped prior to completion? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans Does FDA reject nonclinical laboratory studies that have not been conducted in full compliance with the GLPs? 1.31K viewsDrugsPharmaceutical « Previous 1 2 … 20 21 22 23 24 … 82 83 Next » Question and answer is powered by anspress.net
