Nonclinical Safety Assessment: An Introduction for Statisticians
Fig. 9.1 Nonclinical safety studies which may be conducted for a typical drug project Even before any ‘wet work’ is conducted to support the safety aspects of a drug project,…
GWAS for Drug Discovery
Drug name Drug indication(s)a Effect allele(s) (Reference) Method of allele identification Abacavir HIV-1 (U.S. Food and Drug Administration et~al. 2013) Multiorgan clinical syndrome HLA-B*5701 (Mallal et~al. 2002) Candidate gene ACE…
Statistical Methods for Drug Discovery
Fig. 4.1 A graphical representation of the compound optimization process The next chapter is a thorough summary of practical and statistical aspects of analyzing data from large-scale screening campaigns. Phenotypic screens…
Introduction to Nonclinical Statistics for Pharmaceutical and Biotechnology Industries
Fig. 1.1 Drug discovery and development process 1.1.2 Chemistry, Manufacturing and Control (CMC) After a lead compound is discovered and moves through different development stages, a supply of the compound…
Quantitative-Structure Activity Relationship Modeling and Cheminformatics
Although SMILES strings have their limitations they have proven to be an effective representation of a compound. To create many types of models, some numeric representation of the structure is…
Biomarkers
Gold standard Positive Negative New biomarker Positive TP FP PPV = TP/(TP + FP) Negative FN TN NPV = TN/(TN + FN) Sensitivity = TP/(TP + FN) Specificity = TN/(TN + FP) TP true positives, FP false positives, FN false negatives, TN true…
How To Be a Good Nonclinical Statistician
© Springer International Publishing Switzerland 2016Lanju Zhang (ed.)Nonclinical Statistics for Pharmaceutical and Biotechnology IndustriesStatistics for Biology and Health10.1007/978-3-319-23558-5_3 3. How To Be a Good Nonclinical Statistician Bill Pikounis1 and Luc Bijnens2 (1) Janssen Research and Development,…
