Safety aspects have increasingly become an outstanding issue in the drug discovery and development arena with the FDA and the EMEA placing a clear emphasis on their importance.
The point is illustrated in the book Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays, co-authored by Dr. Franz Hock, CorDynamics European Business Development Director.
Sequential Development: The Paradigm of the Past
Up until 15 years ago, drug discovery and evaluation was a single, sequential process starting with the selection of the most active compound from a series of newly synthesized agents by means of special pharmacological assays.
• Safety aspects were addressed by pharmacological testing of the selected compound in high doses in assays directed at targets other than the intended indication of the new compound.
• These tests were followed by pharmacokinetic studies, which were mainly aimed at confirming a suitable half-life and oral activity.
• Safety aspects relied mostly on toxicity studies, which however gave information on changes of organ structure rather than on organ function.
• Toxicological and pharmacokinetic studies were adapted to the progress of studies in clinical pharmacology and clinical trials.
Simultaneous Data Generation: Today’s Paradigm
The sequential way of working has been replaced by simultaneous generation of data.
• Concurrent safety, pharmacodynamic and pharmacokinetic data is generated.
• If need be, bench-to-bedside and bedside-to-bench approaches can be facilitated to connect preclinical and clinical data as early as possible.
• Rather than a separation into toxicology, pharmacokinetics and clinical applications, a connectivity between all these disciplines is embraced.
This new paradigm is seen as mandatory in the eyes of regulatory bodies as well as among academic thought-leaders and drug development executives.
The industry as a whole has come to understand there is no real safety evaluation possible without combining toxicological, pharmacodynamic and pharmacokinetic data both from a preclinical and from a clinical environment.
To learn more on the topic or to order Dr. Hock’s book, click here.
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