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? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the GLP requirements that are applicable to computerized data – acquisition systems? 1.51K viewsDrugsPharmaceutical 0 Votes 1 Ans Does raw data collected in nonclinical laboratory studies have to be cosigned by a second individual? 1.45K viewsDrugsPharmaceutical 0 Votes 1 Ans Who assesses protocol validity (Number of animals, test article dosage, test system, etc.)? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the GLPs require that absorption studies be done on each test article? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the protocol have to list the SOPS used in a specific study? 1.51K 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? 1.03K viewsDrugsPharmaceutical 0 Votes 1 Ans How does the agency view interim reports of nonclinical laboratory studies? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans How are protocol deviations, which are discovered after the completion of the study to be handled? 1.23K 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? 1.45K viewsDrugsPharmaceutical 0 Votes 1 Ans Does everyone who participated in a study have to be identified in the final report? 1.42K 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? 1.14K 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 1.34K 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? 1.33K 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? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans Can a study director or a pathologist be responsible for storing and retaining specimens and raw data? 1.40K 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? 1.51K viewsDrugsPharmaceutical 0 Votes 1 Ans Where should the QAU records be retained? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans What should be done about nonclinical laboratory studies that are stopped prior to completion? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans Does FDA reject nonclinical laboratory studies that have not been conducted in full compliance with the GLPs? 1.38K viewsDrugsPharmaceutical « Previous 1 2 … 20 21 22 23 24 … 82 83 Next » Question and answer is powered by anspress.net
