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Pre Clinical Toxicity Evaluation of Recombinant Pegylated Granulocyte Colony Stimulating Factor (Rh PEG-GCSF) | Abstract

Asian Journal of Pharmaceutical Technology and Innovation (ajpti)

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Pre Clinical Toxicity Evaluation of Recombinant Pegylated Granulocyte Colony Stimulating Factor (Rh PEG-GCSF)

Abstract

Arunkumar Choulam*, Swapna Basa, Ravikumar B., Prashanth R.

Recombinant protein technology produces drugs for human therapy in unprecedented quantity and quality. Pegfilgrastim is in a class of medications called colony stimulating factors. It works by helping the body make more neutrophils. The aim of the present study is to carry preclinical toxicity study on Acute toxicity and Skin sensitization study by using recombinant Pegylated Granulocyte Colony Stimulating Factor in rats and mice-Acute toxicity study and Guine pigs – skin sensitization test. The objective is to assess the safety profile of rh PEG-GCSF in Swiss albino mice and Sprague Dawley rats and guinea pigs for the treatment of cancer based on the guidelines of EMEA & DBT. In the present study the preclinical toxicity study is carried by conducting Acute Toxicity Study & Guinea Pig Skin Maximisation Test. There was no mortality or morbidity observed during the 14 days study period. No toxic signs and abnormal behaviour was observed in the Group III (Intravenous) and Group IV (subcutaneous) animals, which were exposed to the test compound at 10 times of intended therapeutic dose. There was no mortality or morbidity observed during the 14 days study period. No toxic signs and abnormal behaviour was observed in the Group I (Intravenous) and Group II (subcutaneous) animals, which were exposed to the test compound at 10 times of intended therapeutic dose. On the basis of the results, interpreted according to GPMT Magnusson/Kligman and OECD TG 406, the skin sensitization test in guinea pigs, the substance “rh G-CSF” –pegfilgrastim must be considered as non sensitizer for skin.

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