FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2484985022> ?p ?o ?g. }

• W2484985022 endingPage "75" @default.
• W2484985022 startingPage "35" @default.
• W2484985022 abstract "This paper discusses the challenges and opportunities of implementing the Quality by Design (QbD) and Question based Review (QbR) approaches in developing solid dosage formulations and manufacturing processes for generic drug products. Formulation and process development of a drug product is a challenge due to the inherent variability associated with the activity. Regulatory bodies, such as the Food and Drug Administration (FDA) of the USA, require the QbD approach in developing formulations and processes for drug products. The QbD approach is described in the International Conference on Harmonisation (ICH) guidance Q8 (R2). The regulatory reviewers follow the QbR approach during the review of Chemistry, Manufacturing, and Controls (CMC), which have also adopted some of the elements of the QbD guidance. A systematic application of scientific principles in developing the formulations and processes for generic drug products following the QbD approach is outlined in three main categories. The categories are (A) product understanding, (B) process understanding, and (C) control strategy. The concept of predefined objectives, quality risk management, and CMC considerations along with the prior knowledge are discussed in details. The discussions and explanations provided in this paper are based on sound scientific principles as well as practical experience and approaches applied to resolve product quality and manufacturing issues. Emphasis is given to streamlining the formulations and process development activity to comply with the QbD and QbR principles and to avoid commonly cited deficiencies. The examples are provided as guiding tools for the generic formulation and process development professionals." @default.
• W2484985022 created "2016-08-23" @default.
• W2484985022 creator A5037232900 @default.
• W2484985022 date "2016-07-16" @default.
• W2484985022 modified "2023-09-27" @default.
• W2484985022 title "Mitigating the Risks of Generic Drug Product Development: An Application of Quality by Design (QbD) and Question based Review (QbR) Approaches." @default.
• W2484985022 cites W1498305210 @default.
• W2484985022 cites W1522767714 @default.
• W2484985022 cites W1585499025 @default.
• W2484985022 cites W1840698101 @default.
• W2484985022 cites W1980679195 @default.
• W2484985022 cites W1987563798 @default.
• W2484985022 cites W1991604244 @default.
• W2484985022 cites W1991618236 @default.
• W2484985022 cites W1994203289 @default.
• W2484985022 cites W1998154903 @default.
• W2484985022 cites W2038676839 @default.
• W2484985022 cites W2041131094 @default.
• W2484985022 cites W2045780478 @default.
• W2484985022 cites W2049626994 @default.
• W2484985022 cites W2053207446 @default.
• W2484985022 cites W2070337781 @default.
• W2484985022 cites W2091849182 @default.
• W2484985022 cites W2104192623 @default.
• W2484985022 cites W2107955565 @default.
• W2484985022 cites W2135732933 @default.
• W2484985022 cites W2168866737 @default.
• W2484985022 cites W2183385268 @default.
• W2484985022 cites W2185903804 @default.
• W2484985022 cites W2189301105 @default.
• W2484985022 cites W2267003277 @default.
• W2484985022 cites W2404677638 @default.
• W2484985022 cites W1020595407 @default.
• W2484985022 cites W2286774794 @default.
• W2484985022 cites W2490208655 @default.
• W2484985022 cites W2516618707 @default.
• W2484985022 cites W2994235472 @default.
• W2484985022 hasPublicationYear "2016" @default.
• W2484985022 type Work @default.
• W2484985022 sameAs 2484985022 @default.
• W2484985022 citedByCount "0" @default.
• W2484985022 crossrefType "journal-article" @default.
• W2484985022 hasAuthorship W2484985022A5037232900 @default.
• W2484985022 hasConcept C111472728 @default.
• W2484985022 hasConcept C111919701 @default.
• W2484985022 hasConcept C112930515 @default.
• W2484985022 hasConcept C117671659 @default.
• W2484985022 hasConcept C127413603 @default.
• W2484985022 hasConcept C138885662 @default.
• W2484985022 hasConcept C144133560 @default.
• W2484985022 hasConcept C162853370 @default.
• W2484985022 hasConcept C183696295 @default.
• W2484985022 hasConcept C19351080 @default.
• W2484985022 hasConcept C195094911 @default.
• W2484985022 hasConcept C204320433 @default.
• W2484985022 hasConcept C2524010 @default.
• W2484985022 hasConcept C2779530757 @default.
• W2484985022 hasConcept C33923547 @default.
• W2484985022 hasConcept C41008148 @default.
• W2484985022 hasConcept C539667460 @default.
• W2484985022 hasConcept C90673727 @default.
• W2484985022 hasConcept C98045186 @default.
• W2484985022 hasConceptScore W2484985022C111472728 @default.
• W2484985022 hasConceptScore W2484985022C111919701 @default.
• W2484985022 hasConceptScore W2484985022C112930515 @default.
• W2484985022 hasConceptScore W2484985022C117671659 @default.
• W2484985022 hasConceptScore W2484985022C127413603 @default.
• W2484985022 hasConceptScore W2484985022C138885662 @default.
• W2484985022 hasConceptScore W2484985022C144133560 @default.
• W2484985022 hasConceptScore W2484985022C162853370 @default.
• W2484985022 hasConceptScore W2484985022C183696295 @default.
• W2484985022 hasConceptScore W2484985022C19351080 @default.
• W2484985022 hasConceptScore W2484985022C195094911 @default.
• W2484985022 hasConceptScore W2484985022C204320433 @default.
• W2484985022 hasConceptScore W2484985022C2524010 @default.
• W2484985022 hasConceptScore W2484985022C2779530757 @default.
• W2484985022 hasConceptScore W2484985022C33923547 @default.
• W2484985022 hasConceptScore W2484985022C41008148 @default.
• W2484985022 hasConceptScore W2484985022C539667460 @default.
• W2484985022 hasConceptScore W2484985022C90673727 @default.
• W2484985022 hasConceptScore W2484985022C98045186 @default.
• W2484985022 hasIssue "2" @default.
• W2484985022 hasLocation W24849850221 @default.
• W2484985022 hasOpenAccess W2484985022 @default.
• W2484985022 hasPrimaryLocation W24849850221 @default.
• W2484985022 hasRelatedWork W1182755759 @default.
• W2484985022 hasRelatedWork W191844441 @default.
• W2484985022 hasRelatedWork W199790581 @default.
• W2484985022 hasRelatedWork W2029584965 @default.
• W2484985022 hasRelatedWork W2184470026 @default.
• W2484985022 hasRelatedWork W2255025745 @default.
• W2484985022 hasRelatedWork W2287566608 @default.
• W2484985022 hasRelatedWork W2341325590 @default.
• W2484985022 hasRelatedWork W2496379660 @default.
• W2484985022 hasRelatedWork W2559382184 @default.
• W2484985022 hasRelatedWork W2741892979 @default.
• W2484985022 hasRelatedWork W2742297707 @default.
• W2484985022 hasRelatedWork W2767543607 @default.

• next