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agency amendments animals application appropriate approved archives areas assay audit carcinogenicity changes chemical clinical compliance programs computer system control articles copy corrective actions described determine disqualification documentation Drug Administration drug applications ensure equipment established evaluation FDA inspection FDA's final report Food and Drug functions GLP compliance GLP inspection GLP principles GLP regulations GLP requirements GLP standards identified inspec inspection report investigator issued labora Laboratory Practice maintained Manufacturing Practice marketing permit master schedule ment MOHW nonclinical laboratory study Notification OECD Ortho Ortho Pharmaceutical performed personnel Pharmaceutical protocol quality assurance unit raw data records regulatory research or marketing responsible samples SOPs source code specific specimens sponsor standard operating procedures storage study director submitted systems development teoting test agent test and control test article test or control test system testing facility tion toxicity toxicology validation plan