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LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00003600naa a2200445 4500
001oai:DiVA.org:uu-100027
003SwePub
008090324s2008 | |||||||||||000 ||eng|
0247 a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-1000272 URI
0247 a https://doi.org/10.1208/s12248-008-9034-72 DOI
040 a (SwePub)uu
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a for2 swepub-publicationtype
1001 a Dickinson, Paul A4 aut
2451 0a Clinical relevance of dissolution testing in quality by design
264 c 2008-08-07
264 1b Springer Science and Business Media LLC,c 2008
338 a print2 rdacarrier
520 a Quality by design (QbD) has recently been introduced in pharmaceutical product development in a regulatory context and the process of implementing such concepts in the drug approval process is presently on-going. This has the potential to allow for a more flexible regulatory approach based on understanding and optimisation of how design of a product and its manufacturing process may affect product quality. Thus, adding restrictions to manufacturing beyond what can be motivated by clinical quality brings no benefits but only additional costs. This leads to a challenge for biopharmaceutical scientists to link clinical product performance to critical manufacturing attributes. In vitro dissolution testing is clearly a key tool for this purpose and the present bioequivalence guidelines and biopharmaceutical classification system (BCS) provides a platform for regulatory applications of in vitro dissolution as a marker for consistency in clinical outcomes. However, the application of these concepts might need to be further developed in the context of QbD to take advantage of the higher level of understanding that is implied and displayed in regulatory documentation utilising QbD concepts. Aspects that should be considered include identification of rate limiting steps in the absorption process that can be linked to pharmacokinetic variables and used for prediction of bioavailability variables, in vivo relevance of in vitro dissolution test conditions and performance/interpretation of specific bioavailability studies on critical formulation/process variables. This article will give some examples and suggestions how clinical relevance of dissolution testing can be achieved in the context of QbD derived from a specific case study for a BCS II compound.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Medicinska och farmaceutiska grundvetenskaperx Farmaceutiska vetenskaper0 (SwePub)301012 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Basic Medicinex Pharmaceutical Sciences0 (SwePub)301012 hsv//eng
653 a PHARMACY
653 a FARMACI
7001 a Lee, Wang Wang4 aut
7001 a Stott, Paul W4 aut
7001 a Townsend, Andy I4 aut
7001 a Smart, John P4 aut
7001 a Ghahramani, Parviz4 aut
7001 a Hammett, Tracey4 aut
7001 a Billett, Linda4 aut
7001 a Behn, Sheena4 aut
7001 a Gibb, Ryan C4 aut
7001 a Abrahamsson, Bertilu Uppsala universitet,Institutionen för farmaci4 aut0 (Swepub:uu)berab705
7102 a Uppsala universitetb Institutionen för farmaci4 org
7730 t AAPS Journald : Springer Science and Business Media LLCg 10:2, s. 380-390q 10:2<380-390x 1550-7416
8564 u https://link.springer.com/content/pdf/10.1208%2Fs12248-008-9034-7.pdf
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-100027
8564 8u https://doi.org/10.1208/s12248-008-9034-7

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