High Throughput Innovative Technologies for Physical form Selection and Drug Delivery System to Tet

来源 :中国上海第七届国际新药发明科技年会 | 被引量 : 0次 | 上传用户:guanghui_715
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  Physical form and formulation principle of new chemical entitys (NCEs) play a very important role in preclinical as well as clinical studies.In many disease areas,most of the new chemical entities have a poor aqueous solubility.These are often available in the amorphous and chemically impure form for in-vitro enzyme assay and pharmacokinetic,pharmacological and toxicity studies in animal models.These molecules are often dosed as a suspension/solution and candidate selection is done based on these studies.Prior to preclinical it is very important to characterize the physical form and decide on formulation principle.Selected candidate should be physically and chemically stable during development with comparable pharmacokinetic parameters to those obtained during preclinical research.If bioavailability is significantly different than that obtained from preclinical studies,lot of efforts will be required in formulation development.Ultimately it will increase the time to develop first in human formulation.During preclinical studies it is possible to speed up the process using high throughput innovative technologies for the physical form selection and identify formulation principle using minimum amount of material.This presentation will cover the approaches to help in accelerating the preclinical process during research and avoid development issues for lead candidates by using high throughput innovative technologies.
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