Safety pharmacology data

Dixit, R., What non-clinical toxicology and safety pharmacology data are needed to accelerate phase I—II clinical trials , Am. Pharm. Outsourcing, 5, 30-37, 2004. 

Sophisticated ADME/Tox models and empirical rules derived from increasing amounts of pre-clinical profiling and safety pharmacology data... 

Figure 2.1 The evolution of the drug-likeness concept. Drug-likeness evolved from empirical rules such as Lipinski s rule of 5 through more sophisticated data mining algorithms into utilization of preclinical profiling and safety pharmacology data [3].

The Value of Safety Pharmacology Data the Value and Relevance of Complete, Standardized Data Matrices for In Silica Prediction of Adverse Events... 

Meta Analysis of Safety Pharmacology Data Predicting Compound Promiscuity 13.2.1... 

Valentin JP, Bialecki R, Ewart L, Hammond T, Leishmann D, Lindgren S, Martinez V, Pollard C, Redfem W, Wallis R (2009). A framework to assess the translation of safety pharmacology data to humans. 7 Pharmacol Toxicol Methods 60 152-158. 

Only limited pharmacokinetic (PK) data was available when this compound was submitted for licensing. Furthermore, there was no single-dose toxicology and no safety pharmacology data. It is surprising that no request for this information was made prior to the first dose in man. Fourteen-day repeat-dose toxicity studies... 

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