Basic Regulatory Toxicology - REGULATORY TOXICOLOGY

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    1 REGULATORY  TOXICOLOGY     DESIGN OF PRE CLINICAL TOXICOLOGY STUDIES      Dr.  V. Jagadeesan                        Former Deputy Director ( Sr. Gr. )                                       Food and Drug Toxicology Research Centre ,    Natl. Inst . Nutrition  Hyderabad     Ballantyne et al   General and Applied Toxicology Vol. 1
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    2 REGULATORY  TOXICOLOGY AIM:        To predict what will happen in large,usually  human population , using small number of animals. Doses used in experimental animals is often much larger           than to which the humans are exposed , raising     problems of overloading detoxification systems    Design of Studies :         Prescribed by national / international Agencies , which                set up regulations 
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    3 TYPES OF TOXICITY FUNCTIONAL  :  based on clinical observations-e.g. behavioural            toxicology, Immunotoxicity BIOCHEMICAL:   e.g. mechanism underlying dysfunction ;ADME            of  toxins     STRUCTURAL  :  e.g.pathology based at the level of the  organs/        tissues including  carcinogenesis ENVIRONMENTAL : e.g. Fear what ?Monitor what ? Ban what ? NEWER ASPECTS    :e.g. irritancy, endocrine toxicology, genetic                                   Toxicology, reproductive toxicology,                 including Fertility,teratology, postnatal  development             
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    4 TERMS IN REGULATORY  TOXICOLOGY NEL   : No Effect Level  NOEL  : No Observed Effect Level  NOAEL  : No observed Adverse Effect Level . NEL and NOEL Are  threshold values  to set up   acceptable levels human exposure using some sort  of Safety Factor in the extrapolation from animals to  humans 
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    5 EXPOSURE FIGURES ADI  : acceptable Daily Intake  for chemicals  in food  AOELS:  Acceptable  Operator Exposure   Levels for Chemicals 100 fold safety factor is empirical  *10 for interspecies Differences  *10 for intraspecies Differences 
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  6 TYPICAL DOSE RESPONSE CURVE  (A) (A) Percentage Mortality plotted against the log of the dose  (A) LD50  : Dose of compd that causes 50% mortality in the specified  dosage group under defined conditions (age, gen. hlth, diet etc) (A)  DEATH is the end point here. Sigmoidal curve
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Basic Regulatory Toxicology - REGULATORY TOXICOLOGY

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