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Good Laboratory Practice is a internationally standard for a preclinical testing

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Good Laboratory Practice is a internationally standard for a preclinical testing ... Shemyakin & Ovchinnikov Institute of Bioorganic Chemistry (BRANCH) Russian ... – PowerPoint PPT presentation

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Title: Good Laboratory Practice is a internationally standard for a preclinical testing


1
Good Laboratory Practice is a internationally
standard for a preclinical testing
Arkadi N. Murashev BIOLOGICAL TESTING LABORATORY
Shemyakin Ovchinnikov Institute of Bioorganic
Chemistry (BRANCH) Russian Academy of Sciences
2
Pharmacological Industry
Good Clinical Practice (GCP)
Good Manufacturing Practice (GMP)
Good Laboratory Practice (GLP)
3
Drug Development Scheme
4
Attrition Rate of New Chemical Entities
100,000 Chemicals Examined
Preclinical Evaluation
100 tested in humans
10 Marketed Drugs
6 to 12 Years 600 million to 1.2 billion
Two Drugs Return a Profit
J. A. DiMasi, R. W. Hanson, H. G. Grabowski, L.
Lasagna (1991). the Cost of Innovation in the
Pharmaceutical Industry. J. Health Econom.
10107-142.
5
Complete Toxicology Profile
6
REGULATORS EXPECTATIONS
  • Nonclinical safety studies should be conducted to
    determine the safety of proposed clinical trials
  • Pharmacology (efficacy in vitro and/or in vivo)
  • ADME (Disposition including PK/TK characterize
    exposure at efficacious and toxic doses)
  • Toxicology (Identify safety/hazard in relevant
    test systems)
  • Conducted in conformance with GLPs

7
GLP Documents
International GLP OECD Principles on Good
Laboratory Practice (OECD, ENV/MC/CHEM(98)17,
1997) National USA GLP Good Laboratory Practice
for Nonclinical Laboratory Studies (FDA, 21 CFR
Part 58, Dec 22 1978) National Russia GLP ABOUT
the STATEMENT of RULES of LABORATORY PRACTICE
(Ministry of Health RF, ? 267, Jun 19 2003)
8
GLP Principles
Organization and Personnel Testing facility
management Study director Quality assurance
unit Personnel Conduct of study Standard
operating procedures Protocol Raw data Report
9
GLP Principles
Facilities Animal care facilities Animal supply
facilities Facilities for handling articles
Laboratory operation areas Data storage
facilities Equipment Maintenance and calibration
of equipment CSV Article Characterization and
handling of article
10
TESTING FACILITY
The animal rooms are supplied with 100 outside
air (HEPA filtered) and are maintained at a
positive pressure Temperature (18-26oC) and
humidity (30-70) are controlled 12-hour cycle
of light is synchronized Animals are given a
standard chow and water ad libitum
Total area - 2450 sq.m 13 animal rooms 17
laboratory rooms
11
PLAN OF TESTING FACILITY
12
TESTING FACILITY
Animal care rooms
13
TESTING FACILITY
Animal care rooms
14
TESTING FACILITY
Animal supply area
15
TESTING FACILITY
Area for handling articles
16
TESTING FACILITY
Laboratory operation areas
17
BIOLOGICAL TESTING LABORATORY
TESTING FACILITY MANAGEMENT
STUDY DIRECTORS
QUALITY ASSURANCE UNIT
HANDLING ARTICLE SERVICE
TECHNICIANS
ENGINEERING SERVICE
VETERINARY SERVICE
ARCHIVE
18
Personnel
The organization conducting nonclinical studies
should be completed with the personnel having
necessary education, qualification and experience
  • GLP trainings
  • Into BTL
  • TEMPO
  • Ministry of Health

19
GLP Principles
Animals Standard operating procedures for the
housing, feeding, handling, and care of
animals (AAALAC Accreditation) At the
initiation of a nonclinical study, animals shall
be free of any disease (SPF animals)
20
THANKS! Arkadi N. Murashev murashev_at_fibkh.serpukho
v.su www.fibkh.serpukhov.su
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