Sökning: onr:"swepub:oai:DiVA.org:uu-381432" >
Sensitivity of Pegf...
-
Brekkan, AriUppsala universitet,Institutionen för farmaceutisk biovetenskap,Pharmetheus, Uppsala, Sweden
(författare)
Sensitivity of Pegfilgrastim Pharmacokinetic and Pharmacodynamic Parameters to Product Differences in Similarity Studies
- Artikel/kapitelEngelska2019
Förlag, utgivningsår, omfång ...
-
2019-07-08
-
Springer,2019
-
electronicrdacarrier
Nummerbeteckningar
-
LIBRIS-ID:oai:DiVA.org:uu-381432
-
https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-381432URI
-
https://doi.org/10.1208/s12248-019-0349-3DOI
-
https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-390375URI
Kompletterande språkuppgifter
-
Språk:engelska
-
Sammanfattning på:engelska
Ingår i deldatabas
Klassifikation
-
Ämneskategori:ref swepub-contenttype
-
Ämneskategori:art swepub-publicationtype
Anmärkningar
-
In this work, a previously developed pegfilgrastim (PG) population pharmacokinetic-pharmacodynamic (PKPD) model was used to evaluate potential factors of importance in the assessment of PG PK and PD similarity. Absolute neutrophil count (ANC) was the modelled PD variable. A two-way cross-over study was simulated where a reference PG and a potentially biosimilar test product were administered to healthy volunteers. Differences in delivered dose amounts or potency between the products were simulated. A different baseline absolute neutrophil count (ANC) was also considered. Additionally, the power to conclude PK or PD similarity based on areas under the PG concentration-time curve (AUC) and ANC-time curve (AUEC) were calculated. Delivered dose differences between the products led to a greater than dose proportional differences in AUC but not in AUEC, respectively. A 10% dose difference from a 6 mg dose resulted in 51% and 7% differences in AUC and AUEC, respectively. These differences were more pronounced with low baseline ANC. Potency differences up to 50% were not associated with large differences in either AUCs or AUECs. The power to conclude PK similarity was affected by the simulated dose difference; with a 4% dose difference from 6 mg the power was approximately 29% with 250 subjects. The power to conclude PD similarity was high for all delivered dose differences and sample sizes.
Ämnesord och genrebeteckningar
Biuppslag (personer, institutioner, konferenser, titlar ...)
-
Plan, Elodie L.,1981-Dr. Reddy’s Laboratories, Basel, Switzerland.,Dr Reddys Labs, Basel, Switzerland,Pharmetheus, Uppsala, Sweden(Swepub:uu)elopl609
(författare)
-
Plan, Elodie L.,1981-Pharmetheus, Uppsala, Sweden(Swepub:uu)elopl609
(författare)
-
Nyberg, JoakimPharmetheus, Uppsala, Sweden.
(författare)
-
Kankanwadi, SureshDr. Reddy’s Laboratories, Basel, Switzerland.,Dr Reddys Labs, Basel, Switzerland
(författare)
-
Karlsson, MatsUppsala universitet,Institutionen för farmaceutisk biovetenskap,Pharmetheus, Uppsala, Sweden(Swepub:uu)matskarl
(författare)
-
Uppsala universitetInstitutionen för farmaceutisk biovetenskap
(creator_code:org_t)
Sammanhörande titlar
-
Ingår i:AAPS Journal: Springer21:851550-7416
Internetlänk
Hitta via bibliotek
Till lärosätets databas