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International regulation: the importance of quality assurance in drug development

European Pharmaceutical Review

Since the first ADC was approved by the EMA in 2012, they have generated a great deal of interest in the oncology field because of their potential to address many of the challenges of traditional chemotherapy options. She has worked at organisations including Merck, Novartis, Schering-Plough, and Endo Pharmaceuticals.

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Off-label Use

RX Note

To verify the dosage and off-label use, you may check-up these drug references: Lexicomp - personal preference British National Formulary and BNF for Children Micromedex Medscape Epocrates Yup, technically, you should not look up product leaflet for off-label use (and its dosage). This document is vital for medicolegal purposes.

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Learning Module

RX Note

When the sample concentration is subtherapeutic yet patient is responding well, is dosage adjustment necessary? Post dosage adjustment of sodium valproate, how long should we wait at least prior to TDM reassessment? What are the prechemotherapy checks before initiating chemotherapy. Explain on auto-induction of carbamazepine.