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What recent paediatric guidelines mean for drug developers 

Drug Discovery World

Justin Hay , Senior Director, Amy Cheung Senior Director of Integrated Drug Development, and Patrick Loebs Director, at Certara, examine recent changes in paediatric guidelines and how they affect drug development projects. The section on ethics covers two examples of paediatric ethical factors to consider.

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Webinar: Assessing Cognition Impairment Using Driving Simulators in Clinical Trials

Alta Sciences

Utilizing 10 state-of-the-art simulators available in-house at our Montréal clinical facility (with the capacity for more than 20), we are equipped to measure a range of studies; from impairment in cognition and comparing compounds to assessing the impact on new formulations have on impairment.

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Mission Therapeutics Appoints Dr Suhail Nurbhai as Chief Medical Officer

The Pharma Data

Dr Nurbhai has more than 25 years of experience and a strong track record in the strategic and operational leadership of all phases of clinical research and development at companies across Europe and the US. He joins Mission from VHsquared, where he held the position of CMO since 2014.

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Re-assessing the risks of drug-induced arrhythmias during drug discovery

Drug Discovery World

Unexpected late-stage failures in drug development are, of course, the costliest. The pre-clinical pharmacological effects observed in such experimental model systems need to translate meaningfully into human clinical data to guide effective decision making in drug discovery. 12(3): 197-202. 96(5): 549-558.

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Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

As part of the classification process, we are required to discuss the potential classification before an advisory committee and seek the committee’s recommendation on classification, which took place in October 2014.

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Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

As part of the classification process, we are required to discuss the potential classification before an advisory committee and seek the committee’s recommendation on classification, which took place in October 2014.

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Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

As part of the classification process, we are required to discuss the potential classification before an advisory committee and seek the committee’s recommendation on classification, which took place in October 2014.

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