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S. Guinot - First Evitherm Industry Forum Meeting – September the 15 th 2003 - Paris

DRUG Development in Pharmacuetical Pre-clinical Research. Pre-clinical research and development objective :. To obtain a molecule that is active in animals, ready to be tested in humans witn minimum risk and maximum chances of success. Pharmaceutical sciences :. Preformulation

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S. Guinot - First Evitherm Industry Forum Meeting – September the 15 th 2003 - Paris

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  1. DRUG Development in Pharmacuetical Pre-clinical Research • Pre-clinical research and development objective : • To obtain a molecule that is active in animals, • ready to be tested in humans witn minimum risk and • maximum chances of success. • Pharmaceutical sciences : • Preformulation • Clinical Development • Pharmaceutical Development • Regulatory Affairs S. Guinot - First Evitherm Industry Forum Meeting – September the 15th 2003 - Paris

  2. Pharmaceutical Sciences – Preformulation • Role : establish the physicochemical and biopharmaceutical profile of pharmaceutical compounds to help selection of candidates for clinical administration. • Disciplines : • Chemical analysis : solubility and chemical stability • Physical analysis : solid state profile and stability, polymorphism • Biopharmacy : physico-chemistry and formulation for in vivo • administration S. Guinot - First Evitherm Industry Forum Meeting – September the 15th 2003 - Paris

  3. Purification Crystallisation Formulation Storage Synthesis Administration Storage Distribution Physico-chimistry in the body Preformulation – Physical analysis * * Physical form of the drug is CRUCIAL ! * * S. Guinot - First Evitherm Industry Forum Meeting – September the 15th 2003 - Paris

  4. Physical form of the drug is CRUCIAL ! • to guarantee a good bioavailability • to ensure physical stability during formulation, storage and processing • Most stable and appropriate crystalline form wanted • Solid state parameters needed : • crystallinity * • « physical » purity * • melting temperature * • decomposition temperature * • hygroscopicity • shape and particle size distribution • texture • polymorphic form in general * * Can be obtained by thermal methods S. Guinot - First Evitherm Industry Forum Meeting – September the 15th 2003 - Paris

  5. Thermal info overall needs in a pharmaceutical sciences context • Info (any kind) about thermal analysis and microcalorimetry • equipment suppliers • Basic advices for equipment maintenance and calibration • Thermal database for APIs and excipients • Basic technical and academic knowledge concerning thermal methods • (DSC, MDSC, TGA, Hres TGA, coupling…) • Support for complex thermal methods choice of parameters • (MDSC, HiRes TGA…) • Contacts with experts in the field • Items and/or web links for thermal analysis and calorimetry trainings, workshops, conferences, outsourcing, consultancy, jobs, people… • Thermal bibliography sorted for specific field of interest • (food, pharmaceuticals-polymorphism, cosmetics…) • Support for complex data interpretation Low priority High priority S. Guinot - First Evitherm Industry Forum Meeting – September the 15th 2003 - Paris

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