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Drug Discovery and Evaluation pp 5–13Cite as

Status of Safety Pharmacology and Present Guidelines

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“The adverse drug reactions which the standard toxicological test procedures do not aspire to recognize most of the functional side-effects. Clinical experience indicates, however, that these are much more frequent than the toxic reactions due to morphological and biochemical lesions…” (Gerhard Zbinden 1979)

1 I.B.1. Origins of Safety Pharmacology

Serious injury and/or death of volunteers and patients participating in early clinical trials are rare and thus very disturbing when they occur (Marshall 2001a; 2001b; Miller 2000). The organ systems and functions most frequently responsible in these events are the central nervous (seizure), cardiovascular (hypotension, hypertension, and arrhythmia), respiratory (asthma/bronchoconstriction), and renal (glomerular filtration) systems, and the result is almost always a critical care emergency (Kinter et al. 1997). The origins of safety pharmacology are grounded upon observations that organ functions (like organ structures) can be...

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Author information

Authors and Affiliations

  1. Altstadt 19, 64807, Dieburg, Germany

    Franz J. Hock

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  1. Franz J. Hock
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Correspondence to Franz J. Hock .

Editor information

Editors and Affiliations

  1. Johann-Wolfgang-Goethe-Universität, Frankfurt am Main, Germany

    H. Gerhard Vogel Prof.

  2. Altstadt 19, 64807, Dieburg, Germany

    Franz Jakob Hock Dr. (Editor) (Editor)

  3. Aventis Pharma Deutschland GmbH, Industriepark Hoechst, 65926, Frankfurt, Germany

    Jochen Maas Dr. (Co-Editor) (Co-Editor)

  4. Alte Poststraße 10, 65510, Idstein, Germany

    Dieter Mayer Prof. (Co-Editor) (Co-Editor)

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Hock, F.J. (2006). Status of Safety Pharmacology and Present Guidelines. In: Vogel, H.G., Hock, F.J., Maas, J., Mayer, D. (eds) Drug Discovery and Evaluation. Springer, Berlin, Heidelberg. https://doi.org/10.1007/3-540-29804-5_2

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