Category: 記事

By easing regulatory requirements for animal testing, the Act allows scientists to use innovative, leading-edge technologies more fully in future drug development strategies.

More than a simple report, clinical evaluation now needs to be part of the medical device design process to ensure sufficient clinical evidence, avoid nonconformance and questions from the notified bodies (NB). In this article, we explain the stages of clinical evaluation and required documentation, the literature protocol and review, key components of the CER, … Continued

Model informed drug development (in silico modelling) continues to be a game changer in accelerating drug development. Quantitative Systems Pharmacology (QSP) is one such technology, which employs virtual patients in virtual clinical trials, allowing more approaches to be investigated than would be possible in the real world. Examples described here demonstrate the impact on some … Continued

Modelling and simulation (M&S) plays a crucial role in drug development. It allows information from diverse sources – pre-clinical and in-vitro data, early and late-stage clinical trial data, biomarkers, and efficacy outcomes – to be included with a dataset. Modelling enables researchers to visualize complex scenarios and determine what will happen if a parameter is … Continued

One word you don’t hear too often in current political discourse relating to Brexit is ‘streamlining’; but that’s exactly what the UK’s regulator hoped its Innovation Passport, which forms part of the Innovation Licensing and Access Pathway, would do for getting new drugs on the market more effectively when it was launched in early 2021.

Vyasa has developed deep-learning artificial intelligence solutions for organizations looking to solve the complex data challenges associated with healthcare and …

By: Claire Dyer, Director Global Submissions; Justin Hay, Senior Director; Daniel Smith, Director Regulatory Strategy Brexit reached a significant milestone at the end of January 2023 – three years since the United Kingdom left the European Union. Whilst we’ll be debating its relative merits and pitfalls for decades to come, here in the pharmaceutical industry … Continued

By: Rajesh Krishna, PhD, FAAPS and Steve Sibley According to the National Institutes of Health, more than 30 million people in the United States are affected by a rare disease. Defined in the Orphan Drug Act as any disease that affects less than 200,000 people in the United States, rare diseases total more than 7,000 … Continued

The market access function is an important one, but based on my experience, it is often misunderstood and the timing of when it should be added to the corporate leadership team.. (cont.)

For some time now, cancer drug developers have known “Project Optimus” and new dose optimization expectations are coming their way from the Food and Drug Administration’s (FDA) Oncology Center of Excellence for Oncology Drugs… By Julie Bullock, PharmD