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Achieving pharmaceutical drug traceability compliance

European Pharmaceutical Review

Key attributes of an enterprise resource planning (ERP) system required for drug traceability has been published in a Universal Journal of Pharmacy and Pharmacology paper. The post Achieving pharmaceutical drug traceability compliance appeared first on European Pharmaceutical Review.

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MHRA Chief Executive to step down

European Pharmaceutical Review

While she is stepping down from her current role, Dame June shared that she still hopes to contribute] “to patient safety and public health in other ways” “It has been an enormous privilege to have led the MHRA through a time of change which is unprecedented in UK medical products regulation.

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Handling HPAPIs safely – what does it take?

European Pharmaceutical Review

Highly potent active pharmaceutical ingredients (HPAPIs) are used in formulations for high potent drugs, owing to their ability to target precise disease cells including cancer cells. ” Highly potent APIs are pharmacologically and biologically active compounds at low doses. What are the current trends of HPAPIs?

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How to Become a Pharmaceutical Sales Representative

Pharmaceutical Representative Training

What is a pharmaceutical sales representative? Pharmaceutical sales representatives (often times referred to as pharma reps) are hired by pharmaceutical/biotech companies to educate healthcare providers (HCPs) such as physicians, pharmacists, nurses, and physician assistants (PAs) on their company’s product.

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Increasing efficacy in extractables and leachable testing

European Pharmaceutical Review

A paper published in Regulatory Toxicology and Pharmacology has proposed a consistent, health protective read-across methodology for extractables and leachables (E&Ls). The Extractables Leachables Safety Information Exchange (ELSIE) ’s safety team developed the methodology for generating permitted daily exposures (PDEs) for E&Ls.

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Otsuka and Lundbeck’s sNDA for Rexulti gains US FDA approval

Pharmaceutical Technology

Otsuka Pharmaceutical and H Lundbeck have received approval for the supplemental new drug application (sNDA) from the US Food and Drug Administration for Rexulti (brexpiprazole) to treat agitation associated with dementia due to Alzheimer’s disease. The regulator accepted and gr anted priority review for the sNDA in January 2023.

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Lipid Nanoparticles Immunogenicity & Toxicity | December 6-8, 2022

pharmaphorum

The highly anticipated Lipid Nanoparticle Immunogenicity & Toxicity Summit takes place this December to unite 80+ senior leaders as the definitive meeting for clinical pharmacology , immunogenicity , bioanalytical development leaders to stay at the forefront, arming you with practical takeaways and lessons learned.