Assessment of Toxicity & Environment Carcinogenises

Assessment of Toxicity & Environment Carcinogenises -...

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ASSESSEMENT OF TOXICITY ENVIRONMENTAL CARCINOGENESIS Dr. V. JAGADEESAN Former Deputy Director (Senior Grade) FOOD AND DRUG TOXICOLOGY RESEARCH CENTRE NATIONAL INSTITUTE OF NUTRITION Indian Council of Medical Research Hyderabad - 500 007
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ASSESSEMENT OF TOXICITY
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T he safety assessment of a pharmaceutical compound is the evaluation and characterisation of the adverse effects (Toxicity) of the agent when administered at various doses. The word "safe" in association with therapeutic drugs should never be inferred to mean "without toxicity", because safe is a relative term that depends on many factors such as dose, concentration, species, state of health, method of administration or application. In the 16th century Parcelius stated it in a way that is even for relevant now that "all substances are poison; there is none which is not a poison. The right dose differentiates a poison and remedy".
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Guidelines for Toxicological Research 1.1 FDA OECD (Organisation for Economic Cooperation and Development) ICH 1.2 G.L.P.
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Toxicological protocol consists of acute, sub-acute and chronic testing. Acute toxicity tests is carried out to establish the upper limits of toxicity. Repeated administration of the compound for a short duration as well for a larger duration are carried out to elicit any adverse effect on a long term administration. During sub-acute and chronic studies, the following aspects need to be taken into account Species used Route of administration Duration Criteria of response Biochemical hematological, organ changes plus any specific parameters The rate of clearance of the drug from the body and its interaction with body constituents, (which together comprise of pharmacokinetic and pharmacodynamic studies) can also be evaluated.
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SAFETY EVALUATION OF DRUGS/CHEMICALS Tests to be performed Laboratory Animal Toxicology Clinical studies Oral toxicity – rats, mice Ocular irritation – rabbits Dermal irritation – rabbits, rats, guinea pigs Allergenicity Microbiological Assays Animal Bioassays Feeding studies Protein utilization Consulting Liaison with regulatory agencies Data evaluation and interpretation GLP review
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Mutagenicity and carcinogenicity testing - Animal studies A scheme was drawn up for an evaluation process comprising three tiers, a first tier of submammalian tests for detecting mutagenic activity. These include sex linked recessive lethal test in Drosophila as well as the well known Ames Test using Salmonella. A number of biochemical tests like induction of biphenyl-2 hydroxylase activity and degranulation of microsomes are also included. A second tier of tests like cytogenetic studies in whole mammal, for detecting mutagenic activity. A third tier of risk evaluation which would attempt to determine
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This note was uploaded on 10/07/2010 for the course DBT 456 taught by Professor Ss during the Spring '10 term at Indian Institute of Technology, Guwahati.

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Assessment of Toxicity & Environment Carcinogenises -...

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