Abstract：
PURPOSE:In vitro in vivo correlation (IVIVC) is a biopharmaceutical tool recommended for use in formulation development. When validated, IVIVC can be used to set dissolution limits and, based on the dissolution limits, as a surrogate for an in vivo study. The purpose of this paper is to study the various methods used to fix dissolution limits. METHODS:Fixing dissolution limits is not a straightforward process; various approaches exist. The classical ±10% of dissolution limits was compared to the recommended ±10% of Cmax and AUC and to an innovative back calculation of the 90% CI. Based on simulated values the influence of the calculation method as well as of the variability of the results and pharmacokinetic processes was investigated. RESULTS:Depending upon the method, the results are different and their comparison leads to possible rules. It appears that the usage of a back calculation of a 90% CI is an accurate and advantageous method when intra-individual variability associated with the drug is low. Those findings are in accordance with the current practice of IVIVC, which is not recommended for highly variable drugs. CONCLUSIONS:The approach of using a 90% CI allows the intra-subject variability to be taken into account and fixes limits that ensure a greater chance to show acceptable BE, in case of reasonable intra-subject variability, leading to setting broader in vitro dissolution limits compared to classical solutions.
journal_name
Pharm Resjournal_title
Pharmaceutical researchauthors
Roudier B,Davit BM,Beyssac E,Cardot JMdoi
10.1007/s11095-014-1349-8subject
Has Abstractpub_date
2014-09-01 00:00:00pages
2529-38issue
9eissn
0724-8741issn
1573-904Xjournal_volume
31pub_type
杂志文章abstract：PURPOSE:Development of a human mitochondrial gene delivery vector is a critical step in the ability to treat diseases arising from mutations in mitochondrial DNA. Although we have previously cloned the mouse mitochondrial genome in its entirety and developed it as a mitochondrial gene therapy vector, the human mitochon...
journal_title：Pharmaceutical research
pub_type： 杂志文章
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更新日期：2011-11-01 00:00:00
abstract：PURPOSE:The clinical utility of anthracyclines like idarubicin (IDA) is limited by the occurrence of multidrug resistance and cardiotoxicity. Previous studies have demonstrated that the multidrug transporter P-glycoprotein (P-gp) is present in the heart and have suggested that it exerts a protective function. We sought...
journal_title：Pharmaceutical research
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journal_title：Pharmaceutical research
pub_type： 杂志文章
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journal_title：Pharmaceutical research
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更新日期：2015-11-01 00:00:00
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journal_title：Pharmaceutical research
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更新日期：2015-06-01 00:00:00
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更新日期：2012-12-01 00:00:00
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更新日期：2017-12-01 00:00:00
abstract：:One of the authors has his name incorrectly indexed in PubMed and SpringerLink as "Laird Forrest M" (last name "Laird Forrest"). His name should index as "Forrest M. Laird" with last name as "Forrest". ...
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pub_type： 杂志文章,已发布勘误
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更新日期：2018-07-25 00:00:00
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journal_title：Pharmaceutical research
pub_type： 杂志文章,评审
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更新日期：2020-06-03 00:00:00
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journal_title：Pharmaceutical research
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更新日期：2008-02-01 00:00:00
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journal_title：Pharmaceutical research
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更新日期：2018-03-29 00:00:00
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journal_title：Pharmaceutical research
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doi：10.1007/s11095-005-5356-7
更新日期：2005-07-01 00:00:00
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doi：10.1023/a:1022672608657
更新日期：2003-03-01 00:00:00
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journal_title：Pharmaceutical research
pub_type： 杂志文章
doi：10.1007/s11095-012-0910-6
更新日期：2013-03-01 00:00:00
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journal_title：Pharmaceutical research
pub_type： 杂志文章
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更新日期：2004-12-01 00:00:00
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更新日期：2015-07-01 00:00:00
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journal_title：Pharmaceutical research
pub_type： 杂志文章
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更新日期：2012-11-01 00:00:00
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更新日期：2013-08-01 00:00:00
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pub_type： 杂志文章
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更新日期：1994-05-01 00:00:00
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journal_title：Pharmaceutical research
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更新日期：1989-01-01 00:00:00
abstract：PURPOSE:Models to predict membrane-water partition coefficients (Kp) as a function of drug structure, membrane composition, and solution properties would be useful. This study explores the partitioning of dexamethasone (Dex) and its ionizable 21-phosphate (Dex-P) in liposomes varying in acyl chain length, physical stat...
journal_title：Pharmaceutical research
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更新日期：2013-12-01 00:00:00
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更新日期：2006-09-01 00:00:00
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journal_title：Pharmaceutical research
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更新日期：2011-06-01 00:00:00
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journal_title：Pharmaceutical research
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更新日期：2012-05-01 00:00:00
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journal_title：Pharmaceutical research
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更新日期：2004-12-01 00:00:00
