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Pharmacokinetics - Articles and news items

BAX 826

First patient dosed in BAX 826 haemophilia A Phase I trial

Industry news / 4 March 2016 / Victoria White

BAX 826 is a next-generation rFVIII treatment based on the full length Advate that uses proprietary polysialic acid technology to extend its circulating half-life…

neoGAA

Phase I/II data for neoGAA in Pompe disease presented

Industry news / 4 March 2016 / Victoria White

Sanofi Genzyme says the safety and efficacy data from the NEO1 study support further development of neoGAA…

Man on a phone analysing data and charts on computer screen

Integrating preclinical data into early clinical development

Contract Research, Issue 4 2012 / 3 September 2012 / Vikash Sinha, Clinical Pharmacology Leader, Janssen Research and Development

One of the important goals in preclinical and early clinical drug development is to reduce attrition rates and to improve our ability to pick winners and drop potential loser drug candidates. By being able to efficiently translate preclinical data and observations into possible clinical outcomes, one can make the drug development process more cost-effective. Identifying preclinical models – in silico, in vitro, in vivo – or assays that can best predict clinical observations is not trivial. It requires understanding of preclinical-to-clinical correlations and the success of translational science may vary depending on the therapeutic area where one is working. For example, anti-infectives or cancer therapeutic areas have validated biomarkers which can be useful in selecting the right drug candidate in early drug development…

Pills Powder

Evolution of drug metabolism and pharmacokinetics in drug discovery and development

Drug Discovery, Issue 3 2012 / 10 July 2012 / Dr. Dermot McGinnity, Innovative Medicines, AstraZeneca R&D

Drug Metabolism and Pharmacokinetics (DMPK) is a scientific discipline once primarily associated with safety evaluation in drug development that has, in the last two decades, become a core discipline within drug discovery, development and even post-marketing. Approximately 20 years ago, sub-optimal DMPK properties were recognised as a contributor to the failure of potential new therapies in early clinical trials and this precipitated the realignment of DMPK within discovery to assist in selecting optimal drug candidates to enter clinical trials. In addition to adequate potency against the target protein and an acceptable safety profile, a balance of optimised PK parameters and minimised drug-drug interaction (DDI) potential maximises the chance of a candidate drug becoming a successful therapy…

 

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