目标产品概况TPP与目标产品质量概况QTPP区别在哪？

隐月

两者的区别主要体现在哪方面，QTPP是否还需要体现临床用途、原料质量、容器相容性、药代动力学这些内容？相对于TPP，QTPP的侧重在哪？

静水蓝心

包含与被包含关系

隐月

静水蓝心 发表于 2017-2-12 11:41
包含与被包含关系

能否讲讲具体怎么回事，谢谢

beiwei5du

Target Product Profile (TPP)
A format for a summary of  a drug development program described in terms of  labeling concepts to facilitate communication regarding a particu-lar drug development program
Note: TPP is used as a tool that facilitates sponsor-regulator interactions and communication. Consequently, the TPP contains such information as Drug Indications and Use; Dosage and Administration; Dosage Forms and Strengths; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Abuse and Dependence; and Overdose that are not covered under the scope of  this document  .
应该是像楼上说的包含和被包含的关系。

beiwei5du

Guidance for Industry and Review Staff Target Product Profile — A Strategic Development Process Tool
https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm080593.pdf

Zalmann

A prospective summary of the quality characteristics of a (drug) product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the (drug) product.
QTPP describes a drug product’s desired quality, identifying the key characteristics related to its desired efficacy and safety profile. Its content is derived from the Target Product Profile’s (TPP) content.
 For SM products, the first version of the QTPP must be published prior to the start of DP market formulation development while for LM products the QTPP must be published prior to the start of Process Design activities. The final version needs to be completed and approved prior to filing.
 At minimum, the content of the QTPP will include:
 Route of administration, intended use (e.g. in a clinical setting or at home) and patient population
 Dosage form and strength
 Delivery system(s) (e.g. medical device constituent)
 Shelf life and storage conditions
 Container closure system
 Pharmacokinetics (therapeutic moiety release or delivery)
 Attributes affecting pharmacokinetic or pharmacodynamic characteristics
 Trade Dress (SM only)
 Drug Product target attributes (e.g. sterility, purity, stability and drug release) for marketed product
 The TDT needs to evaluate if there is impact to the QTPP’s content whenever subsequent changes are made to the TPP, and if so, update the document and disseminate the revision to the impacted stakeholders
 For product’s with an approved marketing authorization, a new QTPP must be generated for new indications and/or line extensions. In the instances of new indications, the product’s annotated labeling (submitted with the product’s NDA or BLA), may be referenced as an alternative source of information if no TPP is generated

yuheng

beiwei5du 发表于 2017-9-20 23:11
Guidance for Industry and Review Staff Target Product Profile — A Strategic Development Process Too ...

FDA的链接没有这份文件了，求提供

小金库

感谢分享。

药视小秘书

FEICHANGBULCKNHC;SNHC;loashxdnq

伊索在路上

Zalmann 发表于 2020-7-17 17:26
A prospective summary of the quality characteristics of a (drug) product that ideally will be achiev ...

这是哪个文件的描述，可以分享一下吗？

青椒炒肉

有木有中文的官方解释？