Specific Pharmacology Sample Clauses

Specific Pharmacology. In vivo dose related activity in an appropriate/validated disease model (if possible) by proposed clinical route. Investigate whether effects are related to mechanism of action DG * The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Completion of selectivity profile DG Description of synthesis (non-clinical quality) Feasibility assessment that API can be produced at large scale Chemical Development /Medicinal Chemistry * * Chemical Development /Medicinal Chemistry Program for selection of API form (salt, free base, acid) * Chemical Development /Medicinal Chemistry / GPD Identification of back up compounds and criteria for selection Chemical Development /Medicinal Chemistry Availability of reference compounds (if necessary) Chemical Development /Medicinal Chemistry/ Stability, early estimate According to prerequisites from TPP regarding formulations / routes of administration GPD AnSc / GPD PhSc * The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. First physico-chemical data: solubility, log P, enantiomers, salts, modifications, polymorphs GPD AnSc / GPD PhSc Preliminary assessment of chiral or diastereomeric purity GPD AnSc / GPD PhSc Identification of suitable preclinical formulation for identified candidate (from base or salt form) GPD AnSc / GPD PhSc * * Project Leader / Project Manager Gene mutation (mutagenicity: A▇▇▇ II) * DSE Clastogenicity (in vitro MNT) * DSE * The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. HERG channel assay: ratio HERG IC50 to pharmacologically active concentration (ED50 or ED90 depending on indication) * DSE I▇▇▇▇ test (CNS) and Hemodynamic (BP, HR) in rats: safety margin as compared to plasma level at efficacious dose in animal model * DSE Specific toxicities: depending on risks potentially associated with a) the targeted (identified from literature and/or KO/siRNA studies), b) the chemical series (e.g. Target Backup Blueprint, D▇▇▇▇), or c) results of first-in-class profiling (e.g. TD50 toxicogenomics) As defined by LG plan on a case-by...