Determine development strategy based on client development objectives (generic/innovative drugs/innovative formulations), conduct pre-prescribing studies, and determine feasibility of prescribing process.
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Dissociation constant (pKa)
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Partition/distribution coefficient (Log D/P)
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Intrinsic solubility (So)
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Biopharmaceutics classification system (BCS)
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Formulation development with high bioavailability (amorphous/nanoparticle/nanoemulsion, etc.)
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Solubility studies (water/pH1.2~pH12 solution/organic solvent/simulated intestinal fluid FaSSIF/FeSSIF/simulated gastric fluid FaSSGF/FeSSGF)
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Stability (solution stability, solid stability, heat/light/acid/alkali/oxidation stability) and compatibility of raw materials and excipients