Fig. 18.1 Building blocks of quality by design Table 18.1 Descriptions of the building blocks of quality by design Building block Description Critical quality attributes (CQAs) The critical process output…
Fig. 8.1 Basis for QTiSA-HT cardiac liability assay. The upper panel depicts a ventricular action potential, an electrical response of a ventricular myocyte plotted as the change in transmembrane potential…
is the 100(1-α)th percentile of the F distribution with (2x + 2) and (2n − 2x) degrees of freedom. Then Table 19.1 Consumer’s and producer’s risk quality points for potential PPQ acceptance sampling plans…
Fig. 25.1 NMR spectra before and after pre-treatment In order to eliminate the effects caused by the differing magnitudes of different variables, auto-scaling (or center and scale) can be used….
Fig. 10.1 Flow chart for sequential trend testing The advantage of trend testing methods is that for monotonic dose–response patterns, the methods are more sensitive than pairwise comparisons alone. Note…
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,…
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…
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…
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…
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…
