Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Pharmaceutical water System Biofilm-Growth through Penetration – How quickly can 0.2 micron filters suffer from growth through penetration 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the difference between retest date and expiration date for drug substances? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans 1.Whether Study sample analysis will be conducted before long term stability completion.(Bio analytical) 2.Immediately after completion of validation,long term stability in Biological matrix is required? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans If there is dead biofilm present in the water system, will this show itself with higher TOC counts? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Are you familiar with reports on aspergilli in hospital water systems? Any pertinence to Purified Water systems for pharma? 1.44K viewsDrugsPharmaceutical 0 Votes 1 Ans how capa helps pharmaceutical industry 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans Are photocopies of raw data, which are dated and verified by signature of the copier, considered to be “exact” copies of the raw data? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans Are animal cage cards considered to be raw data? 1.32K viewsDrugsPharmaceutical 0 Votes 1 Ans Are subcontractor laboratories that furnish a particular service such as ophthalmology exams, reading of animal ECGs, EEGs, EMGs, preparation of blocks and slides from tissues, statistical analysis and hematology covered by the GLPs? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it possible to obtain an exemption from specific provisions of the GLPs for special nonclinical laboratory studies? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the GLPs apply to all of the analytical support work conducted to provide supplementary data to a safety study? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the GLPs apply to safety studies on cosmetic products? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans Do safety studies done to determine the potential drug-abuse characteristics of a test article have to be done under the GLPs? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the GLPs apply to validation trials conducted to confirm the analytical methods used to determine the concentration of test article in animal tissues and drug dosage forms? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Must a sponsor reveal toxicology data already collected on a test article to a contract laboratory? 1.45K viewsDrugsPharmaceutical 0 Votes 1 Ans Must a contractor include in the final report information on test article characterization and stability when such information has been collected by the sponsor? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans Do contract laboratories have to show the sponsor’s name on the Master Schedule Sheet or can this information be coded? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans Who is responsible for test article characterization – the sponsor or the contractor? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans A firm functions as a primary contractor for nonclinical laboratory studies. The actual studies are then subcontracted to nonclinical laboratories. Is the firm considered to be a “sponsor?” 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the GLPs require that a sponsor approve the study director for a contracted study? 1.50K viewsDrugsPharmaceutical « Previous 1 2 … 15 16 17 18 19 … 82 83 Next » Question and answer is powered by anspress.net
