VSE knjižnice (vzajemna bibliografsko-kataložna baza podatkov COBIB.SI)
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Predictive potential of acido-basic properties, solubility and food on bioequivalence study outcome [Elektronski vir] : analysis of 128 studiesKrajcar, Dejan ...Background and objectives: Risk assessment related to bioequivalence study outcome is critical for effective planning from the early stage of drug product development. The objective of this research ... was to evaluate the associations between solubility and acido-basic parameters of an active pharmaceutical ingredient (API), study conditions and bioequivalence outcome. Methods: We retrospectively analyzed 128 bioequivalence studies of immediate-release products with 26 different APIs. Bioequivalence study conditions and acido-basic/solubility characteristics of APIs were collected and their predictive potential on the study outcome was assessed using a set of univariate statistical analyses. Results: There was no difference in bioequivalence rate between fasting and fed conditions. The highest proportion of non-bioequivalent studies was for weak acids (10/19 cases, 53%) and neutral APIs (23/95 cases, 24%). Lower non-bioequivalence occurrence was observed for weak bases (1/15 cases, 7%) and amphoteric APIs (0/16 cases, 0%). The median dose numbers at pH 1.2 and pH 3 were higher and the most basic acid dissociation constant (pKa) was lower in the non-bioequivalent group of studies. Additionally, APIs with low calculated effective permeability (cPeff) or low calculated lipophilicity (clogP) had lower non-bioequivalence occurrence. Results of the subgroup analysis of studies under fasting conditions were similar as for the whole dataset. Conclusion: Our results indicate that acido-basic properties of API should be considered in bioequivalence risk assessment and reveal which physico-chemical parameters are most relevant for the development of bioequivalence risk assessment tools for immediate-release products.Vir: Drugs in R&D. - ISSN 1179-6901 (Vol. 23, iss. 3, 2023, str. 211-220)Vrsta gradiva - e-članek ; neleposlovje za odrasleLeto - 2023Jezik - angleškiCOBISS.SI-ID - 155412483
Avtor | Krajcar, Dejan ... |
Naslov | Predictive potential of acido-basic properties, solubility and food on bioequivalence study outcome [Elektronski vir] : analysis of 128 studies |
Datum objave | 2023-06-10 |
COBISS.SI-ID | 155412483 |
Verzija objave v repozitoriju | Založnikova različica |
Licenca objave v repozitoriju | Creative Commons Priznanje avtorstva 4.0 Mednarodna |
Embargo | Takojšnja javna objava |
Projekti, iz katerih je bila financirana objava
Naziv | Akronim | Številka projekta | Financer |
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Farmacevtska tehnologija: od dostavnih sistemov učinkovin do terapijskih izidov zdravil pri otrocih in starostnikih | P1-0189-2018 |
Javna agencija za znanstvenoraziskovalno in inovacijsko dejavnost Republike Slovenije |
Datoteke, ki spadajo k objavi
Povezava |
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https://link.springer.com/article/10.1007/s40268-023-00426-6 |
https://repozitorij.uni-lj.si/IzpisGradiva.php?id=152194 |
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Leto | Faktor vpliva | Izdaja | Kategorija | Razvrstitev | ||||
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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Ime baze podatkov | Področje | Leto |
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Povezave do osebnih bibliografij avtorjev | Povezave do podatkov o raziskovalcih v sistemu SICRIS |
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Krajcar, Dejan | |
Jereb, Rebeka | 50714 |
Legen, Igor | 20369 |
Opara, Jerneja | 14105 |
Grabnar, Iztok | 16107 |
Vir: Osebne bibliografije
in: SICRIS
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