Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 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? 982 viewsDrugsPharmaceutical 0 Votes 1 Ans How does the agency view interim reports of nonclinical laboratory studies? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans How are protocol deviations, which are discovered after the completion of the study to be handled? 1.18K 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? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans Does everyone who participated in a study have to be identified in the final report? 1.36K 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? 1.10K 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 1.29K 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? 1.27K 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? 1.36K viewsDrugsPharmaceutical 0 Votes 1 Ans Can a study director or a pathologist be responsible for storing and retaining specimens and raw data? 1.34K 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? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans Where should the QAU records be retained? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans What should be done about nonclinical laboratory studies that are stopped prior to completion? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans Does FDA reject nonclinical laboratory studies that have not been conducted in full compliance with the GLPs? 1.34K 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? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans Who signs the conforming amendment statement? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans For contracted nonclinical laboratory studies, who is responsible for preparing the GLP compliance statement required by the conforming amendments? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans How extensive should the conforming amendment statement be for preliminary exploratory studies that are exempt from GLP coverage? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans Do acute studies not done in conformity with the GLPs have to be identified in the conforming amendment statement? 1.16K viewsDrugsPharmaceutical 0 Votes 1 Ans How do searches work in Drugs@FDA? 1.12K viewsDrugsPharmaceutical « Previous 1 2 … 20 21 22 23 24 … 79 80 Next » Question and answer is powered by anspress.net
