Current Practices in Safety Pharmacology

Bass, Alan S.; Siegl, P. K. S.; Gintant, Gary A.; Murphy, Dennis J.; Porsolt, Roger D.

doi:10.1002/9780470249055.ch18

Cited by 2 publications

(1 citation statement)

References 100 publications

(132 reference statements)

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“…The assays recommended in the ICH guidelines are discussed in detail in several places [7,12,13]. In this chapter safety pharmacology is presented as an activity in the drug development tool box to facilitate progression of drug candidates through key decision and regulatory milestones and is not limited to the core assays described in the ICH S7A and S7B guidelines.…”

Section: Consideration In Design Of Safety Pharmacology Studiesmentioning

confidence: 99%

Reducing Drug Attrition: Safety Pharmacology

Siegl¹

2013

Topics in Medicinal Chemistry

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Safety pharmacology studies have been used to support drug discovery and development programs by many sponsors for decades. The objectives of these studies are to identify and characterize pharmacology activities of drug candidates that can contribute to adverse effects and safety of clinical trial participants and patients. International guidelines for safety pharmacology were adopted in 2001 and 2005, and results from these studies are now a component of almost all regulatory submissions. By insuring the quality of the data from these studies and effectively communication results in terms of a risk assessment, the safety pharmacology package can be used to identify drug candidates with lower risk for attrition and to mitigate or better manage safety risks during clinical development.

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Section: Consideration In Design Of Safety Pharmacology Studiesmentioning

confidence: 99%

Reducing Drug Attrition: Safety Pharmacology

Siegl¹

2013

Topics in Medicinal Chemistry

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Exploratory Safety Pharmacology: a new safety paradigm to de-risk drug candidates prior to selection for regulatory science investigations

Cavero¹

2009

Expert Opinion on Drug Safety

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The primary objective of Safety Pharmacology is to ensure the safety of medicines on physiological functions in order to protect humans against adverse drug reactions. Safety Pharmacology became a major non-clinical discipline in 2000 when the International Conference on Harmonization approved the S7A guideline. This regulatory document requires pharmaceutical companies to undertake Safety Pharmacology assessment under Good Laboratory Practice (GLP) in order to guarantee the absence of unmanageable risks on vital organ function for compounds to be tested on humans. These regulatory studies often reveal liabilities impacting on the smooth transition of drug candidates from the discovery phase into the clinical arena. However, if these safety issues were uncovered prior to regulatory science assessment, the chemistry of poorly safe molecules could be modified during the lead optimisation phase for preventing later occurring attrition accidents. This article proposes the establishment of a spin-off specialty of Regulatory Safety Pharmacology, for which the name 'Exploratory Safety Pharmacology' is proposed. The objective of this discipline would be to conduct early safety investigations on potential drug candidates by applying, outside the constraints of GLP, in silico, in vitro, ex vivo and in vivo platforms translating clinical liabilities into simple, fast and cost-effective screening assays. This approach should result in early hazard detection with rapid turnaround of the data, enabling medicinal chemists to mitigate the safety liabilities of new compounds in an iterative manner. Hence, the ultimate aim of Exploratory Safety Pharmacology activities is to transform Regulatory Safety Pharmacology investigations into risk-known exercises.

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Current Practices in Safety Pharmacology

Cited by 2 publications

References 100 publications

Reducing Drug Attrition: Safety Pharmacology

Reducing Drug Attrition: Safety Pharmacology

Exploratory Safety Pharmacology: a new safety paradigm to de-risk drug candidates prior to selection for regulatory science investigations

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