Clinical Candidate Database

Key words GVK BIO databases, Medchem database, Toxicity database, Clinical candidate database, GPCR database, Kinase database, GOSTAR, Biomarker database... 

Recruit volunteers who met entrance requirements 2. Screen botanical ingredients for inhibition of IL-1 p production 3. Pilot clinical evaluation of IL-1 inhibitory lead candidate botanicals from activity 2 Establishing a clinical genotyped database Human monocyte cell lines stimulated in vitro with LPS Clinical + laboratory assay of peripheral blood mononuclear cells (PBMCs), and plasma Adequate number of healthy subjects with CRP = 2-10 mg/L and stratified by IL1 composite genotype Select lead candidate botanicals based on IL-1 protein inhibitory dose compared to untreated cultures IL1 gene expression in PBMCs and ex vivo IL-1 production in plasma from test subjects after 2-week dosing of candidate botanicals... 

The interest in the present pharmaceutical industry is very wide spanning the overall drug discovery sphere encompassing data related to small molecules, structure activity relationships, pre-clinical candidates, clinical candidates, launched drugs, biomarkers, toxic molecules, and other target protein inhibitors. While no single database could address all these areas, attempts were made to at least address them individually. We have developed databases... 

Much has been written regarding a proper approach to the development of racemic mixtures of drugs, and whether such drugs are even candidates for development (1,8,22,37-42). As clinical pharmacologists and medical practitioners, we shall advance a point of view that represents a compromise among the various camps, but one that we believe can effectively serve medical therapeutics now and in the future. The previous material in this paper represents a summary, not a comprehensive review, of the database from which attitudes, opinions, and therapeutic approaches can be formulated. 

A Clinical Summary is to start with a subsection on Biopharmaceutical Studies, and Associated Analytical and Bioanalytical Chemistry Methods conducted during the clinical development of a drug candidate. The background of the formulation development process is to be briefly provided and is to include information on in vitro and in vivo dosage form performance and the general approach and rationale for developing the bioavailability (BA), comparative BA, bioequivalence (BE), and in vitro dissolution profile database. Also to be included is a summary of the analytical and bioanalytical chemistry methods and the validation characteristics of these methods. 

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