Application of Pharmacokinetics and Pharmacodynamics in Product Life Cycle Management. A Case Study with a Carbidopa-Levodopa Extended-Release Formulation
作者: Nishit B. Modi
作者单位: 1Impax Specialty Pharma, a division of Impax Laboratories, Inc.
刊名: The AAPS Journal, 2017, Vol.19 (3), pp.607-618
来源数据库: Springer Journal
DOI: 10.1208/s12248-016-0032-x
关键词: Carbidopa-levodopaExtended-releaseFixed-combination productsLife cycle managementPharmacodynamicsPharmacokinetics
英文摘要: Increasing costs in discovering and developing new molecular entities and the continuing debate on limited company pipelines mean that pharmaceutical companies are under significant pressure to maximize the value of approved products. Life cycle management in the context of drug development comprises activities to maximize the effective life of a product. Life cycle approaches can involve new formulations, new routes of delivery, new indications or expansion of the population for whom the product is indicated, or development of combination products. Life cycle management may provide an opportunity to improve upon the current product through enhanced efficacy or reduced side effects and could expand the therapeutic market for the product. Successful life cycle management may include the...
原始语种摘要: Increasing costs in discovering and developing new molecular entities and the continuing debate on limited company pipelines mean that pharmaceutical companies are under significant pressure to maximize the value of approved products. Life cycle management in the context of drug development comprises activities to maximize the effective life of a product. Life cycle approaches can involve new formulations, new routes of delivery, new indications or expansion of the population for whom the product is indicated, or development of combination products. Life cycle management may provide an opportunity to improve upon the current product through enhanced efficacy or reduced side effects and could expand the therapeutic market for the product. Successful life cycle management may include the...
全文获取路径: Springer  (合作)
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影响因子:4.386 (2012)

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关键词翻译
关键词翻译
  • 显影 制品
  • bioequivalence 生物等值
  • levodopa 左旋多巴
  • products 制品
  • developing 制品
  • dosing 配量
  • management 管理
  • efficacy 效验
  • therapeutic 治疗的
  • improved 改进
  • Release 免除释放机构