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Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review

Journal of Biosciences and Medicines 2021年第10期9卷 23-39页

作者： md. imtiaz hasan Shahnaz Akter Shimu Akhi Akther Ishrat Jahan md. Hamiduzzaman A. H. M. Nazmul hasan Department of Pharmacy University of Asia Pacific Dhaka Bangladesh Renata Limited Dhaka Bangladesh

Development of generic drug product by pharmaceutical industry is a scientific and technical approach which is totally different from developing a reference or innovator product. Most of the developing countries focus on developing the generic drug products because huge amount of investment is required for innovation and to develop reference product. The generic medicine has to be bioequivalent to the innovator drug and ensure the same biological effect with proper safety and efficacy. Nowadays, the pharmaceutical industries focus on the development of generic product as this does not require that much time and cost compared to the innovator company. But development of generic product is also difficult as it contains the same therapeutic efficacy as innovator. The development approach is based on the target market, i.e. US market, EU market. If a manufacturer targets the US market, then all excipients should be USP grade, analysis should be conducted by USP method or in-house method and stability studies as well. Prior and during the development of generic drug product API selection, dosage form selection, reference product selection and characterization, formulation development, analytical method development, tech transfer or submission batch are prime concern. Then again, bioequivalence study, drug registration procedure and commercialization of the generic product considering regulatory guidance of respective regulatory agencies and the approaches taken by the regulatory agencies for the development of registration of generic medicines are also crucial as well for the development of generic drug product. The aim of this study was to review the entire stage of a generic drug development by a generic pharmaceutical company.

关键词： Generic Drug Reference Product Pre-Formulation NDA

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Tousled-like kinase 1:a novel factor with multifaceted role in mCRPC progression and development of therapy resistance

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Cancer Drug Resistance 2022年第1期5卷 93-101页

作者： md.imtiaz Khalil Arrigo De Benedetti Department of Biochemistry and Molecular Biology LSU Health Sciences CenterShreveportLA 71103USA

Standard treatment for advanced Prostate Cancer(PCa)consists of androgen deprivation therapy(ADT),but ultimately fails,resulting in the incurable phase of the disease:metastatic castration-resistant prostate cancer(mCRPC).Targeting PCa cells before their progression to mCRPC would greatly improve the outcome,if strategies could be devised selectively targeting androgen receptor(AR)-dependent and/or independent compensatory pathways which promote mCRPC *** therapy by targeting the DNA damage response(DDR)along with ADT has been limited by general toxicity,and a goal of clinical trials is how to target the DDR more *** recent years,our lab has identified a key role for the DDR kinase,TLK1,in mediating key aspects of adaptation to ADT,first by promoting a cell cycle arrest(through the TLK1>NEK1>ATR>Chk1 kinase cascade)under the unfavorable growth conditions(androgen deprivation),and then by reprogramming the PCa cells to adapt to androgen-independent growth via the NEK1>YAP/AR>CRPC *** addition,TLK1 plays a key anti-apoptotic role via the NEK1>VDAC1 regulation on the intrinsic mitochondrial apoptotic pathway when the DDR is ***,TLK1 was recently identified as having an important role in motility and metastasis via regulation of the kinases MK5/PRAK and AKT(indirectly via AKTIP).

关键词： TLK1 NEK1 YAP1 VDAC1 DNA damage response prostate cancer metastatic castration-resistant prostate cancer drug resistance in mCRPC

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Preparation and Structural Properties of ZnAl_xFe_2-xO₄ Spinel Oxide

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American Journal of Analytical Chemistry 2016年第2期7卷 203-209页

作者： Shahzad Hossain Goutam Dev Mst. Sanjida Aktar Muhammad Kamrul hasan A. K. M. Zakaria Tapash Kumar Datta imtiaz Kamal Sk. md. Yunus md. Habibul Ahsan Abul Kalam Azad Institute of Nuclear Science & Technology Bangladesh Atomic Energy Commission Dhaka Bangladesh Faculty of Integrated Technologies Universiti Brunei Darussalam Gadong Brunei Darussalam Department of Physics Shahjalal University of Science and Technology Sylhet Bangladesh

The ZnAlxFe2-xO4 (x = 0.0, 0.2 and 0.4) spinel ferrites were prepared by the conventional solid state reaction in air at 1350°C. The X-ray diffraction of all the three samples showed sharp Bragg peaks indicating the formation of a single phase spinel structure. The lattice parameters of the samples were determined from the X-ray diffraction data using the Nelson-Riley extrapolation method. The lattice parameters, cation distribution and oxygen position parameters have also been determined by refining the data by the Rietveld method. Rietveld refinement of the XRD data reveals all the samples to possess cubic symmetry corresponding to the space group Fd3m. Lattice parameters were found to decrease with increasing Al concentration, i.e. 8.4322, 8.4002, and 8.3984 Åfor x = 0.0, 0.2 and 0.4, respectively.

关键词： Polycrystalline Ferrite X-Ray Diffraction Spinel Ferrite Rietveld Refinement Space Group Fd3m Lattice Parameter

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Potential Solution of Power Flow Constraints of Bangladesh Power System

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Journal of Energy and Power Engineering 2012年第8期6卷 1315-1319页

作者： Nahid-Al-Masood Samsuzzaman Rupu Shaikh Mostafa Fahad Khalid imtiaz Saad md. Quamrul Ahsan Department of Electrical and Electronic Engineering Bangladesh University of Engineering and Technology Dhaka 1000Bangladesh

This paper presents a potential solution of power flow constraints of BPS （Bangladesh power system） using VAR （volt ampere reactive） compensation. VAR compensation is defined as the management of reactive power to improve the performance ofac power systems. The concept of VAR compensation embraces a wide and diverse field of both system and customer problems, especially related with power quality issues, since most of power quality problems can be attenuated or solved with an adequate control of reactive power. VAR compensation in transmission systems also improves the stability of the ac system by increasing the maximum active power that can be transmitted. It also helps to maintain a substantially fiat voltage profile at all levels of power transmission. BPS is currently facing problems in few 132 grid points where the thermal limits of transmission are often exceeded. BPS is also foreseeing problem in transmitting additional power from the new generating units in Sylhet to Dhaka zone. This paper investigates the potential solution to these transmission problems.

关键词： FACTS devices thermal limit VAR compensation power transfer overloading problem.

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Efficacy of Less Toxic Phytochemicals to Prevent the Insect Vector of <i>Mungbean Yellow Mosaic Virus</i>(<i>MYMV</i>)

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American Journal of Plant Sciences 2019年第1期10卷 44-54页

作者： Jesmin Nahar Joly Hosna Ara Chowdhury Abdullah Ali imtiaz Fatema Begum Hasibur Rahman md. Belal Hossain Department of Plant Pathology Sher-e-Bangla Agricultural University Dhaka Bangladesh

Planting material BARI mungbean-5 and two phytochemicals viz. Imitaf, active ingredient imidacloprid and ACmix, active ingredient chloropyriphos (50%) + Cypermethrin (5%) were used in this experiment. In case of Imitaf, the lowest percent disease incidence (10.12% per plant and 3.51% per plot) and severity (7.21%) were recorded in four times spray (T4) at 70 DAS. The highest percent disease incidence (36.50% per plant and 11.37% per plot) and severity (23.33%) were recorded in no spray (T0) at 70 DAS. In case of ACmix, the lowest percent disease incidence (12.21% per plant and 4.21% per plot) and severity (7.53%) were recorded in four times spray (T4) at 70 DAS. The highest percent disease incidence (36.49% per plant and 11.37% per plot) and severity (36.67%) was recorded in T0 at 70 DAS. The highest number of flower, no of pod and yield was found in four times spray (T4) that was higher in Imitaf than ACmix. The highest chlorophyll content was recorded in four times spray (T4) for Imitaf (49.62 μmol·m-2·s-1) and ACmix (56.80 μmol·m-2·s-1), and the lowest chlorophyll content was recorded in T0 for Imitaf (42.01 μmol·m-2·s-1) and ACmix (48.34 μmol·m-2·s-1). However from the results of this experiment it was revealed that Imitaf gave the better performance to control the insect vector (Whitefly) of MYMV with four times spray.

关键词： Mungbean MYMV Whitefly Phytochemicals Bangladesh

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Diagnostic Evaluation of GeneXpert MTB/RIF Assay for the Detection of Rifampicin Resistant Mycobacterium tuberculosis among Pulmonary Tuberculosis Patients in Bangladesh

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Journal of Tuberculosis Research 2016年第1期4卷 55-60页

作者： Hosne Jahan Sanya Tahmina Jhora Zakir H. Habib md. Abdullah Yusuf imtiaz Ahmed Aleya Farzana Rafia Parveen Department of Pathology Shaheed Suhrawardy Medical College Dhaka Bangladesh Department of Microbiology Mugda Medical College Dhaka Bangladesh Department of Microbiology Institute of Epidemiology Disease Control & Research Dhaka Bangladesh Department of Microbiology National Institute of Neurosciences & Hospital Dhaka Bangladesh Department of Microbiology Sir Salimullah Medical College Dhaka Bangladesh Department of Radiology and Imaging Delta Medical College Dhaka Bangladesh

Background: The emergence of multidrug resistant tuberculosis (md.-TB) and extensively drug- resistant tuberculosis (XDR-TB) has highlighted the need for early accurate detection and drug susceptibility. Objective: The purpose of the present study was to evaluate the accuracy of GeneX-pert MTB/RIF assay for the detection of Mycobacterium tuberculosis and rifampicin resistance. Methodology: This cross sectional study was done in the Department of Microbiology at Sir Salimullah Medical College, Dhaka and National Institute of Chest Disease & Hospital (NIDCH), Dhaka during the period of January 2014 to December 2014 for a period of 1 (one) year. Sputum samples from suspected md.-TB patients were collected by purposive sampling technique from OPD of Sir Salimullah Medical College (SSMC) and NIDCH. Microscopy, liquid culture in liquid MGIT 960 media and GeneXpert MTB/RIF were done for MTB diagnosis and detection of rifampicin resistance. MGIT 960 media were also used for determination of drug resistance. Result: Liquid culture yielded higher growth (68%) from 100 samples while GeneXpert MTB assay showed similar result (67% positive and 33% negative). Drug susceptibility test in MGIT 960 media showed that out of 68 positive cases Rifampicin resistant cases were 15 (22.05%) whereas GeneXpert MTB assay detected 14 (20.89%) were Rifampicin resistant out of 67 MTB positive samples. When compared to liquid culture the calculated sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV) and accuracy of GeneXpert MTB were 98.52%, 100%, 96.96%, 100% and 99%. Conclusion: GeneXpert MTB/RIF assay is high detection rate of pulmonary tuberculosis and multidrug resistant tuberculosis.

关键词： md.-TB GeneXpert MTB/RIF Liquid Culture Pulmonary Tuberculosis

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Enhanced 3D Point Cloud Reconstruction for Light Field Microscopy Using U-Net-Based Convolutional Neural Networks

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Computer Systems Science & Engineering 2023年第12期47卷 2921-2937页

作者： Shariar md.imtiaz Ki-Chul Kwon F.M.Fahmid Hossain md.iddut Hossain Rupali Kiran Shinde Sang-Keun Gil Nam Kim Department of Information and Communication Engineering Chungbuk National UniversityCheongju-siChungcheongbuk-do28644Korea Department of Electronic Engineering University of SuwonHwaseong-siGyeonggi-do18323Korea

This article describes a novel approach for enhancing the three-dimensional(3D)point cloud reconstruction for light field microscopy(LFM)using U-net architecture-based fully convolutional neural network(CNN).Since the directional view of the LFM is limited,noise and artifacts make it difficult to reconstruct the exact shape of 3D point *** existing methods suffer from these problems due to the self-occlusion of the *** manuscript proposes a deep fusion learning(DL)method that combines a 3D CNN with a U-Net-based model as a feature *** sub-aperture images obtained from the light field microscopy are aligned to form a light field data cube for preprocessing.A multi-stream 3D CNNs and U-net architecture are applied to obtain the depth feature fromthe directional sub-aperture LF data *** the enhancement of the depthmap,dual iteration-based weighted median filtering(WMF)is used to reduce surface noise and enhance the accuracy of the *** a 3D point cloud involves combining two key elements:the enhanced depth map and the central view of the light field *** proposed method is validated using synthesized Heidelberg Collaboratory for Image Processing(HCI)and real-world LFM *** results are compared with different state-of-the-art *** structural similarity index(SSIM)gain for boxes,cotton,pillow,and pens are 0.9760,0.9806,0.9940,and 0.9907,***,the discrete entropy(DE)value for LFM depth maps exhibited better performance than other existing methods.

关键词： 3Dreconstruction 3Dmodeling point cloud depth estimation integral imaging light filedmicroscopy 3D-CNN U-Net deep learning machine intelligence

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