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? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the GLP requirements that are applicable to computerized data – acquisition systems? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans Does raw data collected in nonclinical laboratory studies have to be cosigned by a second individual? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans Who assesses protocol validity (Number of animals, test article dosage, test system, etc.)? 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the GLPs require that absorption studies be done on each test article? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the protocol have to list the SOPS used in a specific study? 1.48K 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? 1.00K viewsDrugsPharmaceutical 0 Votes 1 Ans How does the agency view interim reports of nonclinical laboratory studies? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans How are protocol deviations, which are discovered after the completion of the study to be handled? 1.20K 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? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans Does everyone who participated in a study have to be identified in the final report? 1.37K 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? 1.11K 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 1.30K 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? 1.29K 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? 1.38K viewsDrugsPharmaceutical 0 Votes 1 Ans Can a study director or a pathologist be responsible for storing and retaining specimens and raw data? 1.36K 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? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans Where should the QAU records be retained? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans What should be done about nonclinical laboratory studies that are stopped prior to completion? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans Does FDA reject nonclinical laboratory studies that have not been conducted in full compliance with the GLPs? 1.36K viewsDrugsPharmaceutical « Previous 1 2 … 20 21 22 23 24 … 82 83 Next » Question and answer is powered by anspress.net
