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Bioavailability and Granule Properties
Published in Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, 2021
Correlation is frequently employed within the pharmaceutical and related sciences to describe the relationship that exists between variables. Mathematically, the term correlation means interdependence between quantitative and qualitative data or the relationship between measurable variables and ranks. Two definitions of IVIVC have been proposed by the USP and by the FDA [32,33].
Bayesian Methods for In Vitro Dissolution Drug Testing and Similarity Comparisons
Published in Emmanuel Lesaffre, Gianluca Baio, Bruno Boulanger, Bayesian Methods in Pharmaceutical Research, 2020
A coherent similarity test requires an unambiguous and actionable definition of what is meant by “similar”. Ideally, the requirements for similarity would be based on those aspects of the dissolution profile critical for safety and efficacy. U.S. Food and Drug Administration (1997b) indicates that this can be achieved if the relationship between IV and in vivo performance is understood (referred to as an in vitro in vivo correlation or IVIVC). In the absence of such a correlation, a number of arbitrary standards of similarity have been advanced in the interest of regulatory due diligence. A comprehensive review of these is found in Zhang et al. (2010).
Biopharmaceutics Aspects of Dermally Applied Drug Delivery Systems
Published in Tapash K. Ghosh, Dermal Drug Delivery, 2020
While some of these concerns have justifiable basis, some may need a further look. While it can be argued that IVRT is not clinically meaningful and IVRT expectations/criteria need clarity, it is difficult to argue against IVRT as a quality test claiming that it is imprecise, unreliable and redundant. For a semisolid product development, a properly developed and validated IVRT can be sensitive to changes in Q3 quality attributes, and can provide performance verification to help mitigate risks associated with potential failure modes and as such adds value to quality control measures. It is important to emphasize that IVRT need not be perfect, or provide in vitro/in vivo correlation (IVIVC), to be highly valuable for quality risk management.
Design and evaluation of glimepiride hydrogel for transdermal delivery
Published in Drug Development and Industrial Pharmacy, 2022
Haiying Li, Jiajia Wang, Qianru Xu, Shuya Tian, Wenzhi Yang
IVIVC is a predicted mathematical model which can be used to predict the in vivo performance of a particular drug according to its in vitro release behavior [23]. A point-to-point level correlation of the GM hydrogels for rabbits was established by plotting the cumulative release amount of GM in vitro (X, Q0-t) versus the absorption (Y, AUC0-t) in vivo (Figure 4(B, C)) The correlation coefficients (R2) were used to evaluate the IVIVC. Q0-t in vitro and AUC0-tin vivo were calculated according to Equation (1 and 3), respectively. As presented in Figure 4(B), the absorption profile in vivo of GM-CP hydrogel is in agreement with the observed release profile in vitro and a good linear relationship was observed (Y = 0.039 X + 5.98, R2=0.974). The equation of GM-HPMC-Pu hydrogel was Y = 0.12 X + 15.71 and the correlation coefficient (R2) was 0.966 (Figure 4(C)). There was a good correlation between skin permeation in vitro and transdermal absorption in vivo using GM hydrogels. The results of IVIVC demonstrated that the drug release in vitro could well predict its absorption in vivo, therefore, in vitro permeation experiments could be utilized to optimize formulations.
In vivo-in vitro correlation of antitumor activity of heat shock protein 90 (HSP90) inhibitors with a pharmacokinetics/pharmacodynamics analysis using NCI-N87 xenograft mice
Published in Xenobiotica, 2021
Noriaki Ohminato, Miho Nagayasu, Kazuhisa Ozeki, Ryoichi Saitoh, Naomi Ono, Norihito Shibahara, Atsushi Suda, Kouichi Yoshinari
In this study, we used the TGI model, because it seemed simple to investigate the IVIVC, considering unbound fractions. We selected the inhibition of cell proliferation for in vitro studies and the tumour growth inhibition in in vivo xenograft efficacy studies as the endpoints. Since the in vitro and in vivo endpoints are similar, it might be one of the reasons why a significant correlation was found between IC50 and EC50. At present, it is unclear whether IVIVC could be meaningfully applied when endpoints of in vitro and/or in vivo studies were changed. In a previous report (Yamazaki 2013), PK/PD modelling of crizotinib was performed using biomarker responses, such as anaplastic lymphoma kinase (ALK) and mesenchymal-epithelial transition as indices for the transition from nonclinical to clinical development. It remains to be evaluated whether the accuracy of IVIVC considering unbound fractions will change in such biomarker-based models in a future study.
Oral controlled release dosage forms: dissolution versus diffusion
Published in Expert Opinion on Drug Delivery, 2020
Marival Bermejo, Barbara Sanchez-Dengra, Marta Gonzalez-Alvarez, Isabel Gonzalez-Alvarez
A recent survey among pharmaceutical companies about developing IVIVC shows that there is a general agreement about its usefulness in developing better mechanistic understanding of potential clinical impact of changes in the formulation and manufacturing process. This knowledge eventually could allow process/formulation changes with a biowaiver approach, setting wider dissolution specifications and supporting the Quality by Design paradigm (QbD). The complexity of the dissolution method could be an issue due to the lack of time and the relatively low throughput of these models compared to standard dissolution apparatus. On the other hand, it seems that based on pharmaceutical companies' experience, finding an adequate dissolution protocol for IR products might sometimes be more challenging than for MR products [93]. In 6 out of the 14 case studies presented, the IVIVC was developed for MR dosage forms using compendial apparatus (mainly USP II). Examples of IVIVC developed with compendial media in USP II and I apparatus can be found for many monolithic and disintegrating controlled release formulations in which diffusion, dissolution, and erosion are the controlling rate steps [94,95].