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QbD and PAT could revolutionise the way biopharma industries operate by cutting down their attrition rates, which could drastically change their business model. This article considers the issues involved.
Designing appropriate non-clinical safety studies requires thoughtful, and sometimes experimental, consideration of the delivery methodology for the therapeutic. The choice of formulation affects drug release and absorption and has a direct impact on the pharmacokinetic profile and associated response of the model system. The formulation should be compatible with the…
This issue celebrates European Pharmaceutical Review's 21st birthday through 21 interviews with leading lights from across the pharmaceutical industry...
As part of EPR’s Women in Pharma series, Andrea Miller, Head of Global R&D and Regulatory Affairs for Mylan, talks to Science Editor Dr Zara Kassam about the importance of being 'team smart', being open to new ideas and listening to other people’s perspectives and learning from them...
With access challenges even after successful but costly development programmes, the industry is under pressure to speed up the clinical development process and produce more for less. Adaptive trial designs, more collaborative working and data sharing could provide a solution in the area of cancer immunotherapy, says Jacqueline Karmel, principal…
As part of EPR’s Women in Pharma series, Catherine Owen, President of Infectious Disease and Vaccines at Johnson & Johnson, talks to Science Editor Dr Zara Kassam about keeping up with the competition, innovation and grasping the breadth of business...
UCB’s ambition, according to its website, is to transform the lives of people living with severe diseases. The company’s Head of Global Clinical Development and Medical Affairs Stuart Dollow believes that making its clinical trial design more patient-centred and creating the right partnerships are key steps toward improving access to…
When the United States Food and Drug Administration (FDA) called for a shakeup of pharmaceutical production in 2002 it recommended the early adoption of technological advances and the application of modern quality management techniques. It believed that this would make manufacturing processes more robust and improve product quality.1
As part of EPR’s Women in Pharma series, Céline Schillinger, Head, Quality Innovation & Engagement at Sanofi Pasteur, talks to Science Editor Dr Zara Kassam about growing modern leadership skills, taking advantage of digital and social technologies and leveraging diversity in decision-making...
Advanced Therapy Medicinal Products (ATMPs) are new therapeutics that require different procedures for clinical trials compared to traditional medicinal products. It is important to understand the nature and the manufacturing process of an ATMP for set-up and execution of the clinical development and later marketing of these therapies.
The EMA recently introduced labelling requirements for some common excipients based on an in-depth assessment of their safety profiles, particularly in the paediatric population.1 This article considers their use in multidose products...
Dr Annalisa Jenkins was the first female doctor to serve on the front line during the conflict in the Gulf War. She talks to EPR as part of our Women in Pharma series, on how her experiences shaped her rationale as a leader, about her views on the importance of…
Film coating is a common step in tablet manufacture that can be used to improve product appearance, organoleptic properties, or to facilitate swallowing. Functional film coats can also be used as a part of the product’s stabilisation strategy and to modify or delay drug release.
Plant extracts have been used in African folk medicine to treat a wide array of infections, especially in Nigeria, for centuries. This article considers the potential medicinal uses and efficacy of the flavonoids epigallocatechin and epicatechin, which can be extracted from the Spondias mombin plant.
In this Separations & Purifications In-Depth Focus: Sample preparation - is it possible to have too much? Discover the value of better quality chemistry; Determination of glucosamine in food supplements by HILIC-ESI-MS; Applying simple PAT tools to crystallisation in process chemistry...
