<i>In Vitro/In Vivo</i> Correlations

Leeson, Lewis J.

doi:10.1177/009286159502900312

Cited by 61 publications

(19 citation statements)

References 4 publications

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“…Time scaling and lag time correction are based on the same approach (2,5,7,11,23). Time scaling and lag time correction are needed if the in vitro and in vivo curves exhibit different rates and/or a difference in the starting of a phenomenon or a difference in lag time.…”

Section: Time Scaling and Lag Time Correctionmentioning

confidence: 99%

“…One tool that can be used in this race against the clock is in vitro-in vivo correlation (IVIVC) and its establishment, when possible, is recommended by authorities (1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)(12). An acceptable IVIVC requires that the in vitro dissolution and in vivo release or dissolution behavior of a dosage form should be either similar or have a scalable relationship to each other.…”

Section: Introductionmentioning

confidence: 99%

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In vitro–In Vivo Correlations: Tricks and Traps

Cardot

Davit

2012

AAPS J

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Abstract. In vitro-in vivo correlation (IVIVC) is a biopharmaceutical tool recommended to be used in development of formulation. When validated, it can speed up development of formulation, be used to fix dissolution limits and also as surrogate of in vivo study. However, as do all tools, it presents limitations and traps. The aim of the present paper is to investigate five common traps which could limit either the setting or use of IVIVC (1) using mean or individual values; (2) correction of absolute bioavailability; (3) correction of lag time and time scaling; (4) flip-flop model; and (5) predictability corrections.

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Section: Time Scaling and Lag Time Correctionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

In vitro–In Vivo Correlations: Tricks and Traps

Cardot

Davit

2012

AAPS J

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“…be adjusted in retrospect,so that dissolution test results may correspond to in vivo outcome (14)(15)(16). Thus,in practice,the experimental conditions,including the use of different apparatus,are adjusted to achieve the desired outcome.…”

Section: Percent Drug Release Profiles Of Three Immediate-release Cmentioning

confidence: 99%

“…Thus,in practice,the experimental conditions,including the use of different apparatus,are adjusted to achieve the desired outcome. This is the currently recommended approach for conducting dissolution testing and is widely practised (6,15). However,it appears that it is based on a flawed logic in that it seeks a desired outcome rather than an evaluation of actual drug release characteristics of the test products.…”

Section: Percent Drug Release Profiles Of Three Immediate-release Cmentioning

confidence: 99%

Developing Discriminatory Drug Dissolution Tests and Profiles: Some Thoughts for Consideration on the Concept and Its Interpretation

Qureshi¹

2006

Dissolution Technol.

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“…The main objective of establishing IV-IVC is to use dissolution test as a surrogate for in vivo bioavailability studies and reduce the need for expensive human studies (Leeson, 1995;Shah and Lesko, 1995). When in vitro-in vivo correlations are established on a formulation, dissolution specifications can be used as a means of controlling drug bioavailability and hence a substitute for human bioequivalence studies .…”

Section: Introductionmentioning

confidence: 99%

In vitro-in vivo correlation of four commercial brands of aspirin tablets marketed in Nigeria

Bamigbola¹,

Ibrahim²,

Attama³

et al. 2011

Afr. J. Pharm. Pharmacol.

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The study investigated the possibility of developing an in vitro -in vivo correlation for four commercial brands of aspirin tablets using USPXXI rotating basket apparatus and urinary excretion profiles from eight human volunteers. Various dissolution and pharmacokinetic parameters were obtained for all the brands. Significant rank order correlations were observed between all the in vitro dissolution parameters such as percent dissolved at 30 min, dissolution rate constants (k) and time for 50% dissolution (DT 50% ) and all the in vivo bioavailability parameters such as cumulative amount excreted up to 8 h (E 8 ), maximum excretion rate (dE/dt) max and time for maximum excretion rate (T max ). However, no correlation could be established between the cumulative amount excreted up to 24 h (E 24 ) and any of the in vitro dissolution parameters. Moreover, statistical analysis showed no significant inter-subject variation among the subjects that participated in the experiments.

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In Vitro/In Vivo Correlations

Cited by 61 publications

References 4 publications

In vitro–In Vivo Correlations: Tricks and Traps

In vitro–In Vivo Correlations: Tricks and Traps

Developing Discriminatory Drug Dissolution Tests and Profiles: Some Thoughts for Consideration on the Concept and Its Interpretation

In vitro-in vivo correlation of four commercial brands of aspirin tablets marketed in Nigeria

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