The Experts below are selected from a list of 137016 Experts worldwide ranked by ideXlab platform
Han Taw Chen - One of the best experts on this subject based on the ideXlab platform.
-
Analysis of the bioheat transfer problem with pulse boundary heat flux using a generalized dual-phase-lag model
International Communications in Heat and Mass Transfer, 2015Co-Authors: Han Taw ChenAbstract:Abstract The present work that extends the study in the literature to that laser irradiation is highly absorbed in the biological tissue and analyzes the problem based on the generalized dual-phase-lag model. A Hybrid Application of the Laplace transform and the modified discretization technique are used to solve the generalized dual-phase-lag model of bioheat transfer with the pulse boundary heat flux. The effects of the coupling factor between blood and tissue, porosity, and the phase lag times on the results are investigated. Comparison between the present results and the results in the literature is made and exposes some interesting phenomena. Results show that the generalized dual-phase-lag model has different temperature evolution from the classical DPL model and the Pennes equation and cannot reduce to the Pennes bio-heat transfer equation for τq = τT, even τq = τT = 0 s.
-
analysis of non fickian diffusion problems in a composite medium
Computer Physics Communications, 2003Co-Authors: Han Taw Chen, Kuochi LiuAbstract:The one-dimensional non-Fickian diffusion problems in a two-layered composite medium for finite and semi-infinite geometry are analyzed by using a Hybrid Application of the Laplace transform technique and control-volume method in conjunction with the hyperbolic shape functions, where the effect of the potential field is taken into account. The Laplace transform method used to remove the time-dependent terms in the governing differential equation and boundary conditions, and then the transformed equations are discretized by the control volume scheme. To evidence the accuracy of the present numerical method, a comparison between the present numerical results and analytical solution is made for the constant potential gradient. Results show that the present numerical results are accurate for various values of the potential gradient, relaxation time ratio, and diffusion coefficient ratio. It can be found that these values play an important role in the present problem. An interesting finding is that when the mass wave encounters an interface of the dissimilar materials, a portion of the wave is reflected and the rest is transmitted. The speed of propagation can change owing to the penetration of the mass wave into the region of the different material. The wave nature is significant only for short times and quickly dissipates with time.
Yuenshin Chen - One of the best experts on this subject based on the ideXlab platform.
-
analysis of heat transfer and burn damage in a laser irradiated living tissue with the generalized dual phase lag model
International Journal of Thermal Sciences, 2016Co-Authors: Yuenshin ChenAbstract:Abstract For considering the non-equilibrium effect, the present paper uses the generalized dual-phase-lag model of bioheat transfer to describe the thermal behavior in a laser irradiated living tissue. The thermal damage is also estimated with the Arrhenius equation. The Hybrid Application of the Laplace transform and the modified discretization technique is employed to solve the present problem. The non-reduction of the generalized dual-phase-lag model to the Pennes equation is further explored. The effects of that the phase lag times depend on the porosity, heat capacities of blood and tissues, coupling factor, and the ratio of thermal conductivity of tissue and blood are taken into account. The results show that the generalized DPL bioheat transfer equation cannot reduce to the Pennes and classical DPL bioheat transfer equations, even with the effect of spatial heating source. Porosity and coupling factor are particularly important to the generalized DPL model. The relation between the phase lag times would demonstrate the characteristics of thermal response in tissue.
Rogerio Gaspar - One of the best experts on this subject based on the ideXlab platform.
-
non biological complex drugs nbcds complex pharmaceuticals in need of individual robust clinical assessment before any therapeutic equivalence decision
Frontiers in Medicine, 2020Co-Authors: Rogerio Gaspar, Beatriz Silvalima, Fernando Magro, A Alcobia, Fernando Leal Da Costa, Jose FeioAbstract:Non-Biological Complex Drugs (NBCDs) are complex non-biological drugs comprised of large high molecular weight molecules and, often, nanoparticular structures (including liposomes and block-copolymer micelles). In the case of NBCDs, the entire complex is the active pharmaceutical ingredient and its properties cannot be fully characterized by physicochemical analysis. Moreover, the manufacturing process is fundamental in creating the correct originator product. The same is true for generic versions of the product. A recent appraisal of approval procedures for NBCDs "follow-on products" approved in Europe shows a diversity of regulatory pathways. In fact, three different abridged Application procedures, under European legislation, were used: the generic Application procedure of Article 10(1), the Hybrid Application procedure of Article 10(3), and the biosimilar Application procedure of Article 10(4). Three informed consent Applications via Article 10(c) from innovator companies of glatiramer acetate and sevelamer carbonate were submitted shortly after the approval of the first follow-on products. Furthermore, a number of "well-established use" Applications [via Article 10(a)] were approved for iron sucrose and iron dextran complexes. In order to protect patients from the increased risks of NBCD products and NBCD follow-on products, two complementary approaches should be considered: (i) improving the regulatory procedures and their guidance documents within the pre-registration phase, and (ii) not considering interchangeability whenever clinical data is not available. With regards to the latter, the need for adequate safety and efficacy data might also include risk management programmes within post-approval pharmacovigilance actions. This, however, would depend on a risk appraisal that must be considered for individual medicinal products, based on the nature of the submitted relevant set of safety/efficacy data.
Jose Feio - One of the best experts on this subject based on the ideXlab platform.
-
non biological complex drugs nbcds complex pharmaceuticals in need of individual robust clinical assessment before any therapeutic equivalence decision
Frontiers in Medicine, 2020Co-Authors: Rogerio Gaspar, Beatriz Silvalima, Fernando Magro, A Alcobia, Fernando Leal Da Costa, Jose FeioAbstract:Non-Biological Complex Drugs (NBCDs) are complex non-biological drugs comprised of large high molecular weight molecules and, often, nanoparticular structures (including liposomes and block-copolymer micelles). In the case of NBCDs, the entire complex is the active pharmaceutical ingredient and its properties cannot be fully characterized by physicochemical analysis. Moreover, the manufacturing process is fundamental in creating the correct originator product. The same is true for generic versions of the product. A recent appraisal of approval procedures for NBCDs "follow-on products" approved in Europe shows a diversity of regulatory pathways. In fact, three different abridged Application procedures, under European legislation, were used: the generic Application procedure of Article 10(1), the Hybrid Application procedure of Article 10(3), and the biosimilar Application procedure of Article 10(4). Three informed consent Applications via Article 10(c) from innovator companies of glatiramer acetate and sevelamer carbonate were submitted shortly after the approval of the first follow-on products. Furthermore, a number of "well-established use" Applications [via Article 10(a)] were approved for iron sucrose and iron dextran complexes. In order to protect patients from the increased risks of NBCD products and NBCD follow-on products, two complementary approaches should be considered: (i) improving the regulatory procedures and their guidance documents within the pre-registration phase, and (ii) not considering interchangeability whenever clinical data is not available. With regards to the latter, the need for adequate safety and efficacy data might also include risk management programmes within post-approval pharmacovigilance actions. This, however, would depend on a risk appraisal that must be considered for individual medicinal products, based on the nature of the submitted relevant set of safety/efficacy data.
Fernando Leal Da Costa - One of the best experts on this subject based on the ideXlab platform.
-
non biological complex drugs nbcds complex pharmaceuticals in need of individual robust clinical assessment before any therapeutic equivalence decision
Frontiers in Medicine, 2020Co-Authors: Rogerio Gaspar, Beatriz Silvalima, Fernando Magro, A Alcobia, Fernando Leal Da Costa, Jose FeioAbstract:Non-Biological Complex Drugs (NBCDs) are complex non-biological drugs comprised of large high molecular weight molecules and, often, nanoparticular structures (including liposomes and block-copolymer micelles). In the case of NBCDs, the entire complex is the active pharmaceutical ingredient and its properties cannot be fully characterized by physicochemical analysis. Moreover, the manufacturing process is fundamental in creating the correct originator product. The same is true for generic versions of the product. A recent appraisal of approval procedures for NBCDs "follow-on products" approved in Europe shows a diversity of regulatory pathways. In fact, three different abridged Application procedures, under European legislation, were used: the generic Application procedure of Article 10(1), the Hybrid Application procedure of Article 10(3), and the biosimilar Application procedure of Article 10(4). Three informed consent Applications via Article 10(c) from innovator companies of glatiramer acetate and sevelamer carbonate were submitted shortly after the approval of the first follow-on products. Furthermore, a number of "well-established use" Applications [via Article 10(a)] were approved for iron sucrose and iron dextran complexes. In order to protect patients from the increased risks of NBCD products and NBCD follow-on products, two complementary approaches should be considered: (i) improving the regulatory procedures and their guidance documents within the pre-registration phase, and (ii) not considering interchangeability whenever clinical data is not available. With regards to the latter, the need for adequate safety and efficacy data might also include risk management programmes within post-approval pharmacovigilance actions. This, however, would depend on a risk appraisal that must be considered for individual medicinal products, based on the nature of the submitted relevant set of safety/efficacy data.
