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Drug Safety - Articles and news items


Champix label updated to include new safety and efficacy data

Industry news / 24 May 2016 / Victoria White, Digital Content Producer

As part of the update, the black triangle symbol, indicating that additional safety monitoring for Champix in the UK was required, has been removed…

Manufacturing & Packaging Supplement 2013

Pharmaceutical Manufacturing & Packaging: In-depth focus 2013

Issue 1 2013, Manufacturing & Packaging, Supplements / 18 February 2013 / Dennis Jenke

The chemical safety assessment process for extractables and leachables associated with packaged pharmaceutical products.
INTERPHEX 2013: Show preview


Ensuring patient safety during clinical trials; translation to preclinical drug discovery

Contract Research, Issue 4 2012 / 3 September 2012 / David Cook & James Milligan, AstraZeneca

Ensuring patient safety during clinical trials is of paramount consideration with stringent monitoring built into trials (and beyond) and the design and interpretation of safety outcomes subject to a large amount of regulation. As a result, it is rare for clinical trials to produce extreme adverse drug reactions but it is also quite common for new medicines to fail in clinical testing due to unacceptable patient safety within a given indication. This is because once a new drug reaches clinical testing, its safety profile is already ‘locked in’, and clinical testing can only discover issues that already exist. The ideal way to ensure the safety of patients is to only progress new medicines into clinical testing which do not have unacceptable safety or tolerability issues. However, to reach this ideal means using learning in the clinic to influence design and development in the laboratory. In this short article, we discuss the practical challenges in doing this and in ‘translating’ patient safety observations such that they can impact on drug design and early development…

In vitro safety pharmacology profiling

Issue 1 2006, Past issues / 2 February 2006 / Jacques Hamon, Kamal Azzaoui, Steven Whitebread, Laszlo Urban, Edgar Jacoby, Bernard Faller, Novartis Institutes for BioMedical Research

One major cause of the late failure of drugs in development (i.e. attrition) is the lack of clinical safety of the compounds (accounting for approximately 30% of failures together with toxicology)1. One of the key elements is the off-target effects of the compounds, causing adverse drug reaction (ADRs).


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