In Vitro-in Vivo Correlations — Quo Vadis

Welling, Peter G.; Forgue, S. Thomas; Cook, J.; deVries, Tina

doi:10.1177/009286159502900311

Cited by 8 publications

(5 citation statements)

References 25 publications

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“…The results indicate that linear correlation models with high r 2 values could be developed for C max and AUC(INF) as a function of the following in vitro parameters: percent dissolved at 2 h, percent dissolved at 4 h, and MDT. These excellent level C correlations are similar to those reported previously for other drugs 4,7,8. An evaluation of the internal predictability for both C max and AUC(INF) indicates that %PE values were < 5% for models using the 4.0‐h dissolution data and in vitro MDT.…”

Section: Discussionsupporting

confidence: 85%

“…Because a level A correlation uses the entire time course of in vitro dissolution and in vivo input, it has been identified as the IVIVC model of choice for the purposes of obtaining biowaivers or setting of dissolution specifications 3. Nevertheless, level B and C models have been reported4,7,8 and may be used in the initial stages of formulation development to examine whether level A IVIVC models are feasible for specific drugs/formulations or, alternatively, to modify in vitro dissolution conditions. The present work aims to develop and evaluate internal predictability of level C and A IVIVC models for the new MR metformin oral dosage form prototypes.…”

Section: Introductionmentioning

confidence: 99%

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In vitro–in vivo correlation (IVIVC) models for metformin after administration of modified‐release (MR) oral dosage forms to healthy human volunteers

Balan

Timmins

Greene

et al. 2001

Journal of Pharmaceutical Sciences

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Section: Discussionsupporting

confidence: 85%

Section: Introductionmentioning

confidence: 99%

In vitro–in vivo correlation (IVIVC) models for metformin after administration of modified‐release (MR) oral dosage forms to healthy human volunteers

Balan

Timmins

Greene

et al. 2001

Journal of Pharmaceutical Sciences

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“…In a recent U.S. regulatory guidance, applications of IVIVC models were outlined. It may be possible to optimize the production of modified-release (MR) dosage forms by using IVIVC models or, alternatively, to predict the in vivo performance of MR dosage forms based on data from in vitro dissolution [8]. It may be possible to optimize the production of modified-release (MR) dosage forms by using IVIVC models or, alternatively, to predict the in vivo behavior of MR dosage forms based on data from in vitro release [8].…”

Section: Introductionmentioning

confidence: 99%

“…It may be possible to optimize the production of modified-release (MR) dosage forms by using IVIVC models or, alternatively, to predict the in vivo performance of MR dosage forms based on data from in vitro dissolution [8]. It may be possible to optimize the production of modified-release (MR) dosage forms by using IVIVC models or, alternatively, to predict the in vivo behavior of MR dosage forms based on data from in vitro release [8]. IVIVC SIGNIFICANCE Pharmaceutical companies are hungry for the rapid production and approval of drugs, while regulatory agencies need product quality and performance assurance.…”

Section: Introductionmentioning

confidence: 99%

In vitro-in vivo correlation (IVIVC) of different parameters of dosage form

Ashraf

Ali

Noreen

et al. 2021

JCP

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Researchers can achieve rapid drug production by discovering a mathematical link between bioavailability and dissolution testing that leads to the principle of in vitro - in vivo correlation (IVIVC). IVIVC is a mathematical model which from its in vitro output can be used to estimate in vivo action. Level A correlation is widely recognized by the regulatory agencies among all the five stages of correlation. IVIVC's suitability is demonstrated by the Biopharmaceutical Classification System (BCS). In the estimation of correlations, dissolution process design plays a central role. Other important parameters in the IVIVC analysis are the qualification of the apparatus and guidelines. During the production of IVIVC, several variables, such as first pass effect, stereochemistry, should be considered. Thus, the need for a method to compare in vitro and in vivo drug release data reliably has increased tremendously. Such an instrument shortens the time of drug growth, saves money and contributes to improved product quality. Increased IVIVC creation activity demonstrates the importance of IVIVCs to the pharmaceutical business. In the production of new pharmaceuticals, IVIVC can be used to minimize the number of human studies during the development of formulation, as the primary objective of IVIVC is to act as a replacement for bioavailability in vivo and to help bio waivers. The usage of dissolution encourages and/or validates methods and configurations for requirements. This is because in vivo importance of in vitro dissolution specifications is included in the IVIVC. Research is based on new oral dosage forms in the current scenario, where awareness of IVIVC is of vital importance. IVIVC implementations vary from drug and product production to improvements in their scale-up and post-approval. Therefore, in drug production, IVIVC should be used as an effective tool

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“…The very notion of establishing and modelling a relationshi p between an in vitro property and an in vivo response has been questioned and must be considered a challenging task (10). The decision that any particular attempt is a success or failure is dependent on the model's ability to describe the in vitro and in vivo data and, most importantly, to make accurate predictions.…”

Section: Introductionmentioning

confidence: 99%

Deconvolution Based Approach for Level A In Vivo-In Vitro Correlation Modelling: Statistical Considerations

Dunne

Gaynor

Davis

2005

Clinical Res. & Regulatory Affairs

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Level A IVIVC models are frequently used to predict the in vivo performance of a drug using only in vitro data; it is therefore advisable to fully investigate the limitations of the methods being used to establish these models. The commonly employed deconvolution approach is examined and the many statistical and modelling problems which arise are introduced. Each issue has an adverse impact on the effectiveness of the model and its ability to make accurate predictions. It becomes apparent that a new modelling approach needs to be developed if we are to achieve our objective of using an IVIVC model to make precise and accurate predictions.

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In Vitro-in Vivo Correlations — Quo Vadis

Cited by 8 publications

References 25 publications

In vitro–in vivo correlation (IVIVC) models for metformin after administration of modified‐release (MR) oral dosage forms to healthy human volunteers

In vitro–in vivo correlation (IVIVC) models for metformin after administration of modified‐release (MR) oral dosage forms to healthy human volunteers

In vitro-in vivo correlation (IVIVC) of different parameters of dosage form

Deconvolution Based Approach for Level A In Vivo-In Vitro Correlation Modelling: Statistical Considerations

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