FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2287782196> ?p ?o ?g. }

• W2287782196 endingPage "591" @default.
• W2287782196 startingPage "581" @default.
• W2287782196 abstract "Quality by design (QbD) is an essential part of the modern approach to pharmaceutical quality. The purpose of this article is to discuss the concept of Quality by Design and describe how it can help to ensure pharmaceutical quality. QbD has to assist both industry and FDA to move towards a more scientific, risk based, holistic and proactive approach to pharmaceutical development. QbD uses a systematic approach to ensure quality by developing a thorough understanding of the compatibility of a finished product to all of the components and processes involved in manufacturing that product. Instead of relying on finished product testing alone, QbD provides insights upstream throughout the development process. Under this concept of QbD throughout designing and development of a product, it is essential to define desire product performance profile i.e. Quality Target Product Profile (QTPP) and identify Critical Quality Attributes (CQA). On the basis of this we can design the product formulation and process to meet the product attributes. This leads to recognise the impact of raw materials [Critical Material Attributes (CMA)], Critical Process Parameters (CPP) on the CQAs and identification and control sources of variability. Implementation of QbD is enabling transformation of the chemistry, manufacturing, and controls (CMC) review of Abbreviated New Drug Applications (ANDAs) into a modern, science and risk based pharmaceutical quality assessment." @default.
• W2287782196 created "2016-06-24" @default.
• W2287782196 creator A5024530300 @default.
• W2287782196 creator A5073184437 @default.
• W2287782196 date "2014-05-28" @default.
• W2287782196 modified "2023-09-24" @default.
• W2287782196 title "Quality by Design: A New Era of Development of Quality in Pharmaceuticals" @default.
• W2287782196 hasPublicationYear "2014" @default.
• W2287782196 type Work @default.
• W2287782196 sameAs 2287782196 @default.
• W2287782196 citedByCount "0" @default.
• W2287782196 crossrefType "journal-article" @default.
• W2287782196 hasAuthorship W2287782196A5024530300 @default.
• W2287782196 hasAuthorship W2287782196A5073184437 @default.
• W2287782196 hasConcept C106436119 @default.
• W2287782196 hasConcept C111472728 @default.
• W2287782196 hasConcept C111919701 @default.
• W2287782196 hasConcept C112930515 @default.
• W2287782196 hasConcept C117671659 @default.
• W2287782196 hasConcept C127413603 @default.
• W2287782196 hasConcept C138885662 @default.
• W2287782196 hasConcept C144133560 @default.
• W2287782196 hasConcept C162853370 @default.
• W2287782196 hasConcept C174998907 @default.
• W2287782196 hasConcept C178144697 @default.
• W2287782196 hasConcept C183696295 @default.
• W2287782196 hasConcept C19351080 @default.
• W2287782196 hasConcept C195094911 @default.
• W2287782196 hasConcept C201995342 @default.
• W2287782196 hasConcept C204320433 @default.
• W2287782196 hasConcept C21547014 @default.
• W2287782196 hasConcept C2524010 @default.
• W2287782196 hasConcept C2778618615 @default.
• W2287782196 hasConcept C2778938233 @default.
• W2287782196 hasConcept C2779530757 @default.
• W2287782196 hasConcept C2779652045 @default.
• W2287782196 hasConcept C2780449318 @default.
• W2287782196 hasConcept C33923547 @default.
• W2287782196 hasConcept C41008148 @default.
• W2287782196 hasConcept C71924100 @default.
• W2287782196 hasConcept C90673727 @default.
• W2287782196 hasConcept C98045186 @default.
• W2287782196 hasConcept C98274493 @default.
• W2287782196 hasConceptScore W2287782196C106436119 @default.
• W2287782196 hasConceptScore W2287782196C111472728 @default.
• W2287782196 hasConceptScore W2287782196C111919701 @default.
• W2287782196 hasConceptScore W2287782196C112930515 @default.
• W2287782196 hasConceptScore W2287782196C117671659 @default.
• W2287782196 hasConceptScore W2287782196C127413603 @default.
• W2287782196 hasConceptScore W2287782196C138885662 @default.
• W2287782196 hasConceptScore W2287782196C144133560 @default.
• W2287782196 hasConceptScore W2287782196C162853370 @default.
• W2287782196 hasConceptScore W2287782196C174998907 @default.
• W2287782196 hasConceptScore W2287782196C178144697 @default.
• W2287782196 hasConceptScore W2287782196C183696295 @default.
• W2287782196 hasConceptScore W2287782196C19351080 @default.
• W2287782196 hasConceptScore W2287782196C195094911 @default.
• W2287782196 hasConceptScore W2287782196C201995342 @default.
• W2287782196 hasConceptScore W2287782196C204320433 @default.
• W2287782196 hasConceptScore W2287782196C21547014 @default.
• W2287782196 hasConceptScore W2287782196C2524010 @default.
• W2287782196 hasConceptScore W2287782196C2778618615 @default.
• W2287782196 hasConceptScore W2287782196C2778938233 @default.
• W2287782196 hasConceptScore W2287782196C2779530757 @default.
• W2287782196 hasConceptScore W2287782196C2779652045 @default.
• W2287782196 hasConceptScore W2287782196C2780449318 @default.
• W2287782196 hasConceptScore W2287782196C33923547 @default.
• W2287782196 hasConceptScore W2287782196C41008148 @default.
• W2287782196 hasConceptScore W2287782196C71924100 @default.
• W2287782196 hasConceptScore W2287782196C90673727 @default.
• W2287782196 hasConceptScore W2287782196C98045186 @default.
• W2287782196 hasConceptScore W2287782196C98274493 @default.
• W2287782196 hasIssue "5" @default.
• W2287782196 hasLocation W22877821961 @default.
• W2287782196 hasOpenAccess W2287782196 @default.
• W2287782196 hasPrimaryLocation W22877821961 @default.
• W2287782196 hasRelatedWork W1546889383 @default.
• W2287782196 hasRelatedWork W1581064108 @default.
• W2287782196 hasRelatedWork W1614947490 @default.
• W2287782196 hasRelatedWork W191844441 @default.
• W2287782196 hasRelatedWork W1989801492 @default.
• W2287782196 hasRelatedWork W2029584965 @default.
• W2287782196 hasRelatedWork W2050829003 @default.
• W2287782196 hasRelatedWork W2182673157 @default.
• W2287782196 hasRelatedWork W2184470026 @default.
• W2287782196 hasRelatedWork W2217801747 @default.
• W2287782196 hasRelatedWork W2255025745 @default.
• W2287782196 hasRelatedWork W2369390289 @default.
• W2287782196 hasRelatedWork W2496379660 @default.
• W2287782196 hasRelatedWork W2559382184 @default.
• W2287782196 hasRelatedWork W2591201851 @default.
• W2287782196 hasRelatedWork W2982234150 @default.
• W2287782196 hasRelatedWork W2995466788 @default.
• W2287782196 hasRelatedWork W3006345436 @default.
• W2287782196 hasRelatedWork W3029847944 @default.
• W2287782196 hasRelatedWork W2186241860 @default.
• W2287782196 hasVolume "7" @default.
• W2287782196 isParatext "false" @default.

• next