1. Drug development phase and timeline
2. labaoratory to medicine cabinet
   1. 10-15 yrs
   2. one billion $$$
3. Stages
   1. Preclinical
      1. In vivo
         1. genotoxicity (mutagenic on bacteria)
         2. determine toxicity and efficacy (at least 2 mammals)
         3. eval. biomarkers
         4. det. drug behavior
            1. pharmacodynamics
            2. pharmacokinetics (what body does to drug)
         5. Main goals
            1. safety
            2. efficacy
      2. GLP
         1. regulations
         2. guidances
         3. history
            1. test site: industrial bio-test-laboraties
            2. CFR21 part 58
            3. 1981 OECD
            4. 1987 FDA revised to make flex.
         4. organization and personnel
            1. personnel
            2. responsiblities
            3. testing facility management
            4. study director
            5. quality assurance unit
            6. facilities
            7. animal care
            8. equipment
         5. protocol for noncli lab study
         6. records and reports
         7. test and control articles
            1. characterzation
            2. handling
            3. protocol
            4. Standard Operating Procedures (SOPS)
         8. enforcemnts (complaiance with GLPS)
            1. BMO
            2. inspections
            3. surveillance inspections
            4. directed inspections
         9. disqualifications
   2. IND