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Journal articles on the topic 'IVIVC'

Author: Grafiati

Published: 4 June 2021

Last updated: 26 July 2025

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1

Polli, James E. "IVIVR versus IVIVC." Dissolution Technologies 7, no. 3 (2000): 6–8. http://dx.doi.org/10.14227/dt070300p6.

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2

Shazia Ashraf, Azka Ali, Uzma Noreen, and Iqra Abdullah Jan. "In vitro-in vivo correlation (IVIVC) of different parameters of dosage form." Journal of Contemporary Pharmacy 5, no. 1 (2021): 28–32. http://dx.doi.org/10.56770/jcp2021514.

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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

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3

Rohankumar Patel and Ankur Patel. "In vivo–In Vitro correlation (IVIVC) in drug development: bridging preclinical and clinical outcomes for regulatory approvals." World Journal of Advanced Research and Reviews 22, no. 2 (2024): 2311–28. https://doi.org/10.30574/wjarr.2024.22.2.1197.

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The pharmacological discipline of In vivo–In Vitro Correlation (IVIVC) plays a crucial role in drug development, creating essential relationships to forecast in vivo PK results from measuring In Vitro drug release profiles. IVIVC models not only prove essential for formulating drugs properly but also significantly reduce time and costs during regulatory processes, thereby limiting extensive clinical testing requirements. These models can predict live performance outcomes through laboratory results, leading to consistent therapeutic outcomes between different medications. The relation between I

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4

Mumtaz, Hina, Muhammad Asim Farooq, Zainab Batool, Anam Ahsan, and Ashikujaman Syed. "Significance of In-Vitro and In-Vivo Correlation in Drug Delivery System." Research in Pharmacy and Health Sciences 4, no. 4 (2018): 523–31. http://dx.doi.org/10.32463/rphs.2018.v04i04.23.

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The main purpose of development pharmaceutical dosage form is to find out the in vivo and in vitro behavior of dosage form. This challenge is overcome by implementation of in-vivo and in-vitro correlation. Application of this technique is economical and time saving in dosage form development. It shortens the period of development dosage form as well as improves product quality. IVIVC reduce the experimental study on human because IVIVC involves the in vivo relevant media utilization in vitro specifications. The key goal of IVIVC is to serve as alternate for in vivo bioavailability studies and

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5

Lee, Dong-Seok, Dong Wook Kang, Go-Wun Choi, Han-Gon Choi, and Hea-Young Cho. "Development of Level A In Vitro–Vivo Correlation for Electrosprayed Microspheres Containing Leuprolide: Physicochemical, Pharmacokinetic, and Pharmacodynamic Evaluation." Pharmaceutics 12, no. 1 (2020): 36. http://dx.doi.org/10.3390/pharmaceutics12010036.

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This study optimized the preparation of electrosprayed microspheres containing leuprolide and developed an in vitro–in vivo correlation (IVIVC) model that enables mutual prediction between in vitro and in vivo dissolution. The pharmacokinetic (PK) and pharmacodynamic (PD) study of leuprolide was carried out in normal rats after subcutaneous administration of electrosprayed microspheres. The parameters of the IVIVC model were estimated by fitting the PK profile of Lucrin depot® to the release compartment of the IVIVC model, thus the in vivo dissolution was predicted from the in vitro dissolutio

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6

Tosca, Elena M., Maurizio Rocchetti, Elena Pérez, et al. "In Vitro–In Vivo Correlation (IVIVC) Population Modeling for the In Silico Bioequivalence of a Long-Acting Release Formulation of Progesterone." Pharmaceutics 13, no. 2 (2021): 255. http://dx.doi.org/10.3390/pharmaceutics13020255.

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Health authorities carefully evaluate any change in the batch manufacturing process of a drug before and after regulatory approval. In the absence of an adequate in vitro–in vivo correlation (Level A IVIVC), an in vivo bioequivalence (BE) study is frequently required, increasing the cost and time of drug development. This study focused on developing a Level A IVIVC for progesterone vaginal rings (PVRs), a dosage form designed for the continuous delivery in vivo. The pharmacokinetics (PK) of four batches of rings charged with 125, 375, 750 and 1500 mg of progesterone and characterized by differ

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7

Ajeh, Isaac J., Galadima I. Hayatu, and Ekeh I. Ezekiel. "Computational prediction of pharmacokinetic parameters as an in vitro approach for assessing paracetamol tablets for IVIVC; a strategy in COVID-19 disruptive times." Journal of Phytomedicine and Therapeutics 21, no. 2 (2022): 835–45. http://dx.doi.org/10.4314/jopat.v21i2.6.

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In vitro-in vivo correlation (IVIVC) is a desirable attribute for any drug dissolution test to establish relevance and confidence in evaluating the quality and safety of products. The pharmacokinetic parameters of paracetamol have been studied extensively but information about the IVIVC is scanty and mostly controversial; this justifies its choice as a model drug for this study. This work is aimed to evaluate and compare the IVIVC dissolution profile of different brands of paracetamol tablets using authentic pharmacokinetic parameters such as; maximum observed dug concentration (Cmax), time to

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8

Čulen, Martin, Paweł K. Tuszyński, Sebastian Polak, Renata Jachowicz, Aleksander Mendyk, and Jiří Dohnal. "Development ofIn Vitro-In VivoCorrelation/Relationship Modeling Approaches for Immediate Release Formulations Using Compartmental Dynamic Dissolution Data from “Golem”: A Novel Apparatus." BioMed Research International 2015 (2015): 1–13. http://dx.doi.org/10.1155/2015/328628.

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Different batches of atorvastatin, represented by two immediate release formulation designs, were studied using a novel dynamic dissolution apparatus, simulating stomach and small intestine. A universal dissolution method was employed which simulated the physiology of human gastrointestinal tract, including the precise chyme transit behavior and biorelevant conditions. The multicompartmental dissolution data allowed direct observation and qualitative discrimination of the differences resulting from highly pH dependent dissolution behavior of the tested batches. Further evaluation of results wa

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9

Prieto-Escolar, Mercedes, Juan J. Torrado, Covadonga Álvarez, et al. "One and Two-Step In Vitro-In Vivo Correlations Based on USP IV Dynamic Dissolution Applied to Four Sodium Montelukast Products." Pharmaceutics 13, no. 5 (2021): 690. http://dx.doi.org/10.3390/pharmaceutics13050690.

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Montelukast is a weak acid drug characterized by its low solubility in the range of pH 1.2 to 4.5, which may lead to dissolution-limited absorption. The aim of this paper is to develop an in vivo predictive dissolution method for montelukast and to check its performance by establishing a level-A in vitro-in vivo correlation (IVIVC). During the development of a generic film-coated tablet formulation, two clinical trials were done with three different experimental formulations to achieve a similar formulation to the reference one. A dissolution test procedure with a flow-through cell (USP IV) wa

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10

Lee, Da Young, Soyoung Shin, Tae Hwan Kim, and Beom Soo Shin. "Establishment of Level a In Vitro–In Vivo Correlation (IVIVC) via Extended DoE-IVIVC Model: A Donepezil Case Study." Pharmaceutics 14, no. 6 (2022): 1226. http://dx.doi.org/10.3390/pharmaceutics14061226.

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This study aimed to establish an extended design of experiment (DoE)-in vitro in vivo correlation (IVIVC) model that defines the relationship between formulation composition, in vitro dissolution, and in vivo pharmacokinetics. Fourteen sustained-release (SR) tablets of a model drug, donepezil, were designed by applying a mixture design of DoE and prepared by the wet granulation method. The in vitro dissolution patterns of donepezil SR tablets were described by Michaelis–Menten kinetics. The mathematical relationship describing the effects of SR tablet compositions on the in vitro dissolution p

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11

Figueroa-Campos, Andrés, Bárbara Sánchez-Dengra, Virginia Merino, et al. "Candesartan Cilexetil In Vitro–In Vivo Correlation: Predictive Dissolution as a Development Tool." Pharmaceutics 12, no. 7 (2020): 633. http://dx.doi.org/10.3390/pharmaceutics12070633.

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The main objective of this investigation was to develop an in vitro–in vivo correlation (IVIVC) for immediate release candesartan cilexetil formulations by designing an in vitro dissolution test to be used as development tool. The IVIVC could be used to reduce failures in future bioequivalence studies. Data from two bioequivalence studies were scaled and combined to obtain the dataset for the IVIVC. Two-step and one-step approaches were used to develop the IVIVC. Experimental solubility and permeability data confirmed candesartan cilexetil. Biopharmaceutic Classification System (BCS) class II

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12

Gan, Yanxiong, Yaxin Xu, Xue Zhang, et al. "Revisiting Supersaturation of a Biopharmaceutical Classification System IIB Drug: Evaluation via a Multi-Cup Dissolution Approach and Molecular Dynamic Simulation." Molecules 28, no. 19 (2023): 6962. http://dx.doi.org/10.3390/molecules28196962.

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As a subclass of the biopharmaceutical classification system (BCS) class II, basic drugs (BCS IIB) exhibit pH-dependent solubility and tend to generate supersaturation in the gastrointestinal tract, leading to less qualified in vitro–in vivo correlation (IVIVC). This study aims to develop a physiologically based multi-cup dissolution approach to improve the evaluation of the supersaturation for a higher quality of IVIVC and preliminarily explores the molecular mechanism of supersaturation and precipitation of ketoconazole affected by Polyvinylpyrrolidone–vinyl acetate copolymer (PVPVA) and hyd

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13

M. Idkaidek, Nasir, Naji Najib, Isam Salem, and Jamal Jilani. "Physiologically-Based IVIVC of Azithromycin." American Journal of Pharmacological Sciences 2, no. 6 (2014): 100–102. http://dx.doi.org/10.12691/ajps-2-6-1.

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14

Park, Kinam. "IVIVC of parenteral PLGA microspheres." Journal of Controlled Release 218 (November 2015): 116. http://dx.doi.org/10.1016/j.jconrel.2015.10.041.

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15

Kim, Namhyuck, Kyoungho Kim, Seungwei Jeong, et al. "Development and Evaluation of Bilayer Sustained-Release Tablets of Ruxolitinib Using Discriminative Pharmacokinetic Analysis and IVIVC." Pharmaceutics 17, no. 4 (2025): 432. https://doi.org/10.3390/pharmaceutics17040432.

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Objectives: This study explores the development and evaluation of a bilayer sustained-release (SR) tablet formulation of ruxolitinib. As a BCS Class 1 drug, ruxolitinib requires twice-daily dosing due to its short half-life. We designed a bilayer tablet that integrates immediate-release (IR) and SR components in varying ratios to achieve sustained plasma concentrations, which we evaluated using discriminative analysis. Methods: Bilayer tablets combining IR and SR components were prepared in different ratios. In vitro dissolution tests and pharmacokinetic studies were conducted using Beagle dog

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16

Nguyen, M. A., T. Flanagan, M. Brewster, et al. "A survey on IVIVC/IVIVR development in the pharmaceutical industry – Past experience and current perspectives." European Journal of Pharmaceutical Sciences 102 (May 2017): 1–13. http://dx.doi.org/10.1016/j.ejps.2017.02.029.

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17

Kushwah, Varun, Sumit Arora, Miklós Tamás Katona, Dattatray Modhave, Eleonore Fröhlich, and Amrit Paudel. "On Absorption Modeling and Food Effect Prediction of Rivaroxaban, a BCS II Drug Orally Administered as an Immediate-Release Tablet." Pharmaceutics 13, no. 2 (2021): 283. http://dx.doi.org/10.3390/pharmaceutics13020283.

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The present work evaluates the food effect on the absorption of rivaroxaban (Riva), a BCS II drug, from the orally administered commercial immediate-release tablet (Xarelto IR) using physiologically based pharmacokinetic (PBPK) and conventional in vitro–in vivo correlation (IVIVC) models. The bioavailability of Riva upon oral administration of Xarelto IR tablet is reported to exhibit a positive food effect. The PBPK model for Riva was developed and verified using the previously reported in vivo data for oral solution (5 and 10 mg) and Xarelto IR tablet (5 and 10 mg dose strength). Once the PBP

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18

D'Souza, Susan, Jabar A. Faraj, Stefano Giovagnoli, and Patrick P. DeLuca. "IVIVC from Long Acting Olanzapine Microspheres." International Journal of Biomaterials 2014 (2014): 1–11. http://dx.doi.org/10.1155/2014/407065.

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In this study, four PLGA microsphere formulations of Olanzapine were characterized on the basis of theirin vitrobehavior at 37°C, using a dialysis based method, with the goal of obtaining an IVIVC.In vivoprofiles were determined by deconvolution (Nelson-Wagner method) and using fractional AUC. Thein vitroandin vivorelease profiles exhibited the same rank order of drug release. Further,in vivoprofiles obtained with both approaches were nearly superimposable, suggesting that fractional AUC could be used as an alternative to the Nelson-Wagner method. A comparison of drug release profiles for the

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19

Park, Kinam. "IVIVC for circulation kinetics of liposomes." Journal of Controlled Release 156, no. 3 (2011): 275. http://dx.doi.org/10.1016/j.jconrel.2011.11.010.

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20

Ali, Hasan, Priya Ranjan Prasad Verma, Sunil Kumar Dubey, et al. "In vitro–in vivo and pharmacokinetic evaluation of solid lipid nanoparticles of furosemide using Gastroplus™." RSC Advances 7, no. 53 (2017): 33314–26. http://dx.doi.org/10.1039/c7ra04038e.

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21

Kim, Tae Hwan, Soyoung Shin, Seok Won Jeong, Jong Bong Lee, and Beom Soo Shin. "Physiologically Relevant In Vitro-In Vivo Correlation (IVIVC) Approach for Sildenafil with Site-Dependent Dissolution." Pharmaceutics 11, no. 6 (2019): 251. http://dx.doi.org/10.3390/pharmaceutics11060251.

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This study aimed to establish a physiologically relevant in vitro-in vivo correlation (IVIVC) model reflecting site-dependent dissolution kinetics for sildenafil based on population-pharmacokinetic (POP-PK) modeling. An immediate release (IR, 20 mg) and three sustained release (SR, 60 mg) sildenafil tablets were prepared by wet granulation method. In vitro dissolutions were determined by the paddle method at pH 1.2, 4.5, and 6.8 media. The in vivo pharmacokinetics were assessed after oral administration of the prepared IR and SR formulations to Beagle dogs (n = 12). The dissolution of sildenaf

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22

Bibi, David, Raphael Bilgraer, Lilach Steiner, and Hussein Hallak. "Physiologically-Based Pharmacokinetic Modeling and In Vitro–In Vivo Correlation of TV-46000 (Risperidone LAI): Prediction from Dog to Human." Pharmaceutics 16, no. 7 (2024): 896. http://dx.doi.org/10.3390/pharmaceutics16070896.

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The interest in the development and therapeutic application of long-acting injectable products for chronic or long-term treatments has experienced exponential growth in recent decades. TV-46000 (Uzedy, Teva) is a long-acting subcutaneous (sc) injectable formulation of risperidone, approved for the treatment of schizophrenia in adults. Following sc injection, the copolymers together with risperidone precipitate to form a sc depot under the skin to deliver therapeutic levels of risperidone over a prolonged period of either 1 month or 2 months, depending upon the dose. This work presents the stra

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23

Cardot, J. M., G. Garrait, and E. Beyssac. "Use of IVIVC to Optimize Generic Development." Dissolution Technologies 22, no. 2 (2015): 44–48. http://dx.doi.org/10.14227/dt220215p44.

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24

R.Natarajan. "DESIGN AND IVIVC OF LAMIVUDINE TRANSDERMAL PATCHES." Journal of Advances in Pharmaceutical Sciences 2, no. 2 (2024): 11–21. https://doi.org/10.5281/zenodo.11058871.

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<em>The transdermal drug delivery system for lamivudine was created utilising the solvent casting method with Span-80 acting as a permeation enhancer. The drug: polymer ratios (Lamivudine: HPMC and Lamivudine: EC) were created in two different ways: one at a ratio of 1:2.5, one at a ratio of 1:5, and one with permeation enhancers. The transdermal patch that was developed had good physical and chemical characteristics, did not cause any skin irritation in the rat skin, and was used in an in vitro drug permeation investigation where the rat skin was kept in phosphate buffer pH 7.4 for a full day

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25

Fonsi, Massimiliano. "Extrahepatic Metabolism may Complicate the IVIVC in Rats." Drug Metabolism Letters 8, no. 1 (2014): 51–66. http://dx.doi.org/10.2174/187231280801140929160226.

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26

Sandell, Dennis. "Bioequivalence assessment of pharmaceutical aerosol products through IVIVC." Advanced Drug Delivery Reviews 176 (September 2021): 113895. http://dx.doi.org/10.1016/j.addr.2021.113895.

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27

Chakraborty, Sumon, Kavan Pandya, and Deepika Aggarwal. "Establishing Prospective IVIVC for Generic Pharmaceuticals: Methodologies Assessment." Open Drug Delivery Journal 5, no. 1 (2014): 1–7. http://dx.doi.org/10.2174/1874126601405010001.

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28

Yadagiri, Phalguna, and Michael Wombeogo. "IN VITRO-IN VIVO CORRELATION (IVIVC): TAMOXIFEN NANOSPHERES." INDIAN DRUGS 61, no. 05 (2024): 68–69. http://dx.doi.org/10.53879/id.61.05.14426.

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The primary goal of this study was to establish an in vitro-in vivo correlation (IVIVC) for tamoxifen (TAM)- loaded polycaprolactone-chitosan nanospheres. The plasma attention of TAM and time records have been used to calculate the pharmacokinetic parameters. Cmax for the nano spheres stayed determined to be 459.20 ng mL-1, compared to 442.20 ng mL-1 for natural TAM. Furthermore, the Wagner-Nelson technique was employed to compare the drug release profile by determining the in vivo fixation time data. In line with this, a level between the intestinal absorption in rats and the dissolution % fo

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29

Langenbucher, Frieder. "IVIVC: Indices for Comparing Release and Response Profiles." Drug Development and Industrial Pharmacy 25, no. 11 (1999): 1223–25. http://dx.doi.org/10.1081/ddc-100102507.

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30

Cook, Jack A. "Development strategies for IVIVC in an industrial environment." Biopharmaceutics & Drug Disposition 33, no. 7 (2012): 349–53. http://dx.doi.org/10.1002/bdd.1791.

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31

Kim, Yejin, Eun Ji Park, Tae Wan Kim, and Dong Hee Na. "Recent Progress in Drug Release Testing Methods of Biopolymeric Particulate System." Pharmaceutics 13, no. 8 (2021): 1313. http://dx.doi.org/10.3390/pharmaceutics13081313.

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Biopolymeric microparticles have been widely used for long-term release formulations of short half-life chemicals or synthetic peptides. Characterization of the drug release from microparticles is important to ensure product quality and desired pharmacological effect. However, there is no official method for long-term release parenteral dosage forms. Much work has been done to develop methods for in vitro drug release testing, generally grouped into three major categories: sample and separate, dialysis membrane, and continuous flow (flow-through cell) methods. In vitro drug release testing als

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32

Barzegar-Jalali, Mohammad, Kaivan Mohammadi, Ghobad Mohammadi, et al. "A Correlative Model to Predict In Vivo AUC for Nanosystem Drug Delivery with Release Rate-Limited Absorption." Journal of Pharmacy & Pharmaceutical Sciences 15, no. 4 (2012): 583. http://dx.doi.org/10.18433/j3np5n.

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Purpose. Drug release from nanosystems at the sites of either absorption or effect biophase is a major determinant of its biological action. Thus, in vitro drug release is of paramount importance in gaining insight for the systems performance in vivo. Methods. A novel in vitro in vivo correlation, IVIVC, model denoted as double reciprocal area method was presented and applied to 19 drugs from 55 nano formulations with total 336 data, gathered from literature. Results. The proposed model correlated the in vitro with in vivo parameters with overall error of 12.4 ± 3.9%. Also the trained version

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33

Mircioiu, Anuta, Mircioiu, Nicolescu, and Fotaki. "In Vitro–In Vivo Correlations Based on In Vitro Dissolution of Parent Drug Diltiazem and Pharmacokinetics of its Metabolite." Pharmaceutics 11, no. 7 (2019): 344. http://dx.doi.org/10.3390/pharmaceutics11070344.

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In this study a novel type of in vitro–in vivo correlation (IVIVC) is proposed: The correlation of the in vitro parent drug dissolution data with the in vivo pharmacokinetic data of drug’s metabolite after the oral administration of the parent drug. The pharmacokinetic data for the parent drug diltiazem (DTZ) and its desacetyl diltiazem metabolite (DTZM) were obtained from an in vivo study performed in 19 healthy volunteers. The pharmacokinetics of the parent drug and its metabolite followed a pseudomono-compartmental model and deconvolution of the DTZ or DTZM plasma concentration profiles was

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34

Lee, Ye-Ji, and Joo-Eun Kim. "In Vitro–In Vivo Correlation of Tianeptine Sodium Sustained-Release Dual-Layer Tablets." Molecules 27, no. 9 (2022): 2828. http://dx.doi.org/10.3390/molecules27092828.

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Tianeptine tablets are currently marketed to be designed for immediate-release tablets. The tianeptine has a short half-life, making it difficult to design for sustained-release tablets and achieve bioequivalence with the tianeptine immediate-release tablet (Stablon®). We established the in vitro–in vivo correlation (IVIVC) of three formulations of tianeptine sustained-release tablets according to their granule size. To evaluate sustained drug release, in vitro tests were performed in pH 1.2 media for 24 h. In vivo pharmacokinetic analysis was performed following oral administration of referen

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35

Bermejo, Marival, Jessica Meulman, Marcelo Gomes Davanço, Patricia de Oliveira Carvalho, Isabel Gonzalez-Alvarez, and Daniel Rossi Campos. "In Vivo Predictive Dissolution (IPD) for Carbamazepine Formulations: Additional Evidence Regarding a Biopredictive Dissolution Medium." Pharmaceutics 12, no. 6 (2020): 558. http://dx.doi.org/10.3390/pharmaceutics12060558.

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The aim of the present study was to bring additional evidence regarding a biopredictive dissolution medium containing 1% sodium lauryl sulphate (SLS) to predict the in vivo behavior of carbamazepine (CBZ) products. Twelve healthy volunteers took one immediate release (IR) dose of either test and reference formulations in a bioequivalence study (BE). Dissolution profiles were carried-out using the medium. Level A in vitro–in vivo correlations (IVIVC) were established using both one-step and two-step approaches as well as exploring the time-scaling approach to account for the differences in diss

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36

Zhang, Yufeng, Siu Kwan Wo, Wei Leng, Fang Gao, Xiaoyu Yan, and Zhong Zuo. "Population pharmacokinetics and IVIVC for mesalazine enteric-coated tablets." Journal of Controlled Release 346 (June 2022): 275–88. http://dx.doi.org/10.1016/j.jconrel.2022.04.024.

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37

Rettig, Harald, and Jana Mysicka. "IVIVC: Methods and Applications in Modified-Release Product Development." Dissolution Technologies 15, no. 1 (2008): 6–8. http://dx.doi.org/10.14227/dt150108p6.

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38

Van Buskirk, Glenn A. "PQRI Workshop Report: Application of IVIVC in Formulation Development." Dissolution Technologies 21, no. 2 (2014): 51–58. http://dx.doi.org/10.14227/dt210214p51.

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39

De Spiegeleer, B., L. Van Vooren, J. Voorspoels, D. Thoné, and J. Rosier. "Dissolution stability and IVIVC investigation of a buccal tablet." Analytica Chimica Acta 446, no. 1-2 (2001): 343–49. http://dx.doi.org/10.1016/s0003-2670(01)01074-1.

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40

Takano, Ryusuke, Makoto Kataoka, and Shinji Yamashita. "Integrating drug permeability with dissolution profile to develop IVIVC." Biopharmaceutics & Drug Disposition 33, no. 7 (2012): 354–65. http://dx.doi.org/10.1002/bdd.1792.

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41

D’Souza, Susan. "A Review of In Vitro Drug Release Test Methods for Nano-Sized Dosage Forms." Advances in Pharmaceutics 2014 (November 20, 2014): 1–12. http://dx.doi.org/10.1155/2014/304757.

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This review summarizes the methods used to study real-time (37°C) drug release from nanoparticulate drug delivery systems and establish an IVIVC. Since no compendial standards exist, drug release is currently assessed using a variety of methods including sample and separate (SS), continuous flow (CF), dialysis membrane (DM) methods, and a combination thereof, as well as novel techniques like voltametry and turbidimetry. This review describes the principle of each method along with their advantages and disadvantages, including challenges with set-up and sampling. The SS method allows direct mea

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42

van Wijk, Rob C., Rami Ayoun Alsoud, Hans Lennernäs, and Ulrika S. H. Simonsson. "Model-Informed Drug Discovery and Development Strategy for the Rapid Development of Anti-Tuberculosis Drug Combinations." Applied Sciences 10, no. 7 (2020): 2376. http://dx.doi.org/10.3390/app10072376.

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The increasing emergence of drug-resistant tuberculosis requires new effective and safe drug regimens. However, drug discovery and development are challenging, lengthy and costly. The framework of model-informed drug discovery and development (MID3) is proposed to be applied throughout the preclinical to clinical phases to provide an informative prediction of drug exposure and efficacy in humans in order to select novel anti-tuberculosis drug combinations. The MID3 includes pharmacokinetic-pharmacodynamic and quantitative systems pharmacology models, machine learning and artificial intelligenc

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43

Puscas, Ina, Florian Bernard-Patrzynski, Martin Jutras, et al. "IVIVC Assessment of Two Mouse Brain Endothelial Cell Models for Drug Screening." Pharmaceutics 11, no. 11 (2019): 587. http://dx.doi.org/10.3390/pharmaceutics11110587.

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Since most preclinical drug permeability assays across the blood-brain barrier (BBB) are still evaluated in rodents, we compared an in vitro mouse primary endothelial cell model to the mouse b.End3 and the acellular parallel artificial membrane permeability assay (PAMPA) models for drug screening purposes. The mRNA expression of key feature membrane proteins of primary and bEnd.3 mouse brain endothelial cells were compared. Transwell® monolayer models were further characterized in terms of tightness and integrity. The in vitro in vivo correlation (IVIVC) was obtained by the correlation of the

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44

Kumar, Pramod, Sanjay Singh, and Brahmeshwar Mishra. "Development and biopharmaceutical evaluation of extended release formulation of tramadol hydrochloride based on osmotic technology." Acta Pharmaceutica 59, no. 1 (2009): 15–30. http://dx.doi.org/10.2478/v10007-009-0010-2.

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Development and biopharmaceutical evaluation of extended release formulation of tramadol hydrochloride based on osmotic technologyExtended release formulation of tramadol hydrochloride (TRH) based on osmotic technology was developed and evaluated. Target release profile was selected and different variables were optimized to achieve it. Formulation variables such as the level of swellable polymer, plasticizer and the coat thickness of semipermeable membrane (SPM) were found to markedly affect drug release. TRH release was directly proportional to the levels of plasticizer but inversely proporti

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Cardot, J.-M., E. Beyssac, and M. Alric. "In Vitro–In Vivo Correlation: Importance of Dissolution in IVIVC." Dissolution Technologies 14, no. 1 (2007): 15–19. http://dx.doi.org/10.14227/dt140107p15.

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Margolskee, Alison, Adam S. Darwich, Aleksandra Galetin, Amin Rostami-Hodjegan, and Leon Aarons. "Deconvolution and IVIVC: Exploring the Role of Rate-Limiting Conditions." AAPS Journal 18, no. 2 (2015): 321–32. http://dx.doi.org/10.1208/s12248-015-9849-y.

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KLEIN, S., M. RUDOLPH, B. SKALSKY, H. PETEREIT, and J. DRESSMAN. "Use of the BioDis to generate a physiologically relevant IVIVC." Journal of Controlled Release 130, no. 3 (2008): 216–19. http://dx.doi.org/10.1016/j.jconrel.2008.06.014.

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Gaynor, Clare, Adrian Dunne, and John Davis. "The Effects of Averaging on Accuracy of IVIVC Model Predictions." Journal of Pharmaceutical Sciences 98, no. 10 (2009): 3829–38. http://dx.doi.org/10.1002/jps.21662.

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Devara, R. K., P. Reddipogu, S. Kumar, B. Rambabu, A. Jithan, and M. Habibuddin. "INVESTIGATION OF SOLUBILITY ENHANCEMENT OF PRASUGREL HYDROCHLORIDE: NANOSUSPENSIONS AND CYCLODEXTRIN INCLUSION COMPLEXES." INDIAN DRUGS 51, no. 02 (2014): 29–38. http://dx.doi.org/10.53879/id.51.02.p0029.

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The objective of this study was to investigate nanosuspensions, hydroxypropyl-β-cyclodextrin (HPβCD) complexes and SLS powders for enhancing the solubility and dissolution rate of Prasugrel HCl (PHCl) so as to reduce the fluctuations in its oral bioavailability. PHCl nanosuspensions were prepared using evaporative precipitation method. HPβCD inclusion complexes of PHCl were prepared using physical mixture, co-evaporation and kneading methods. Powders of the pure drug with different SLS amounts were prepared. The formulations were characterized using techniques such as powder x-ray diffractomet

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Zhang, Chi, Huihui Shao, Zunsheng Han, et al. "Development and In Vitro–In Vivo Correlation Evaluation of IMM-H014 Extended-Release Tablets for the Treatment of Fatty Liver Disease." International Journal of Molecular Sciences 24, no. 15 (2023): 12328. http://dx.doi.org/10.3390/ijms241512328.

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This study aimed to develop extended-release tablets containing 25 mg IMM-H014, an original drug formulated by a direct powder pressing method based on pharmaceutical-grade hydrophilic matrix polymers such as hydroxypropyl methylcellulose, to establish an in vitro–in vivo correlation (IVIVC) to predict bioavailability. The tablets’ mechanical properties and in vitro and in vivo performance were studied. The formulation was optimized using a single-factor experiment and the reproducibility was confirmed. The in vitro dissolution profiles of the tablet were determined in five dissolution media,

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