April 2022

ICH Guideline For Pharmacovigilance

ICH GUIDELINE FOR PHARMACOVIGILANCE Organization and objective of ICH Expedited reporting Individual case safety reports Periodic safety update reports Post approval expedited reporting Pharmacovigilance planning Good clinical practice in pharmacovigilance studies ORGANIZATION AND OBJECTIVE OF ICH   •       ICH is the international council/conference on harmonization of technical requirement for registration of pharmaceuticals for Human Use. …

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Chemotherapy of Malignancy

CANCER ·         Cancer is the uncontrolled proliferation and abnormal multiplication of cells within the body. ·         A mass of tissue formed as a result of; o   Abnormal o   Excessive o   Uncoordinated o   Autonomous and o   purposeless o   Proliferation of cells THE CELL CYCLE ·         Malignant cells go through normal mitosis but synthesize DNA and divide …

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