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Antibody Drug Conjugates: windows of opportunity

Drug Target Review

1 Regulators invest significant consideration balancing quality-of-life measures with overall survival when assessing novel oncology treatments. Author bios: Dr Petra Dieterich Petra has 30 years’ experience of drug development in the Pharmaceutical industry with a focus on supporting CMC activities.

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FDA Sets a Recommended Framework for Predicting the Mutagenic and Carcinogenic Potential of Nitrosamine Drug Substance-Related Impurities

FDA Law Blog: Biosimilars

Lewis, Senior Regulatory Device & Biologics Expert — Please sing to the tune of “ Honesty ,” by Billy Joel: Nitrosamines, it’s such an ugly word, In pharmaceuticals’ impurity. Nitrosamines are hardly ever good, Now FDA has issued policy.

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Women in STEM with Dr Catherine Sheehan

Drug Target Review

My secondary school chemistry teacher had a PhD in organic chemistry, and I found her classes and lab experiments to be very interesting, especially those in physical and organic chemistry. Excipients, or inactive ingredients in a drug formulation, are critical components.