Mapping Km Methods And Tools Across The Pharmaceutical Product Lifecycle,
2021
TuDublin
Mapping Km Methods And Tools Across The Pharmaceutical Product Lifecycle, Martin Lipa, Paige Kane
Level 3
Knowledge management is positioned as an enabler of ICH Q10, and the visibility and availability of product and process knowledge across the entire pharmaceutical product lifecycle is vital to the sustained success of an organization and to the effectiveness of an organization’s pharmaceutical quality system as defined by ICH Q10. This paper illustrates where knowledge management has a role to play within each product lifecycle phase. This paper goes on to further define phase-appropriate KM methods and tools to help address these needs and create end-to-end product and process knowledge visibility and availability.
Protecting Intestinal Microenvironment Alleviates Acute Graft-Versus-Host Disease,
2021
Tianjin University of Traditional Chinese Medicine
Protecting Intestinal Microenvironment Alleviates Acute Graft-Versus-Host Disease, Zhengcan Zhou, Ting Shang, Xiurong Li, Hongyan Zhu, Yu-Bo Qi, Xin Zhao, Xi Chen, Zhe-Xin Shi, Guixiang Pan, Yue-Fei Wang, Guanwei Fan, Xiumei Gao, Yan Zhu, Benjamin Feng
Peer Reviewed Articles
Acute gut graft-versus-host disease (aGVHD) is a leading threat to the survival of allogeneic hematopoietic stem cell transplantation (allo-HSCT) recipients. Abnormal gut microbiota is correlated with poor prognosis in allo-HSCT recipients. A disrupted intestinal microenvironment exacerbates dysbiosis in GVHD patients. We hypothesized that maintaining the integrity of the intestinal barrier may protect gut microbiota and attenuate aGVHD. This hypothesis was tested in a murine aGVHD model and an in vitro intestinal epithelial culture. Millipore cytokine array was utilized to determine the expression of proinflammatory cytokines in the serum. The 16S rRNA sequencing was used to determine the abundance and diversity …
Understanding Molecular Interaction Between Sulfadoxine And Human Serum Albumin Through Spectroscopic And Molecular Docking Methods,
2021
Universiti Malaya
Understanding Molecular Interaction Between Sulfadoxine And Human Serum Albumin Through Spectroscopic And Molecular Docking Methods, Jaslene Anne Francis
Student Works (2020-2029)
The main aim of this study was to characterize the molecular interaction between sulfadoxine (SDN) and the major transport protein in the blood plasma, human serum albumin (HSA) using fluorescence, absorption, circular dichroism and voltammetric techniques along with computational methods. SDN-induced changes in the fluorescence intensity of HSA hinted the complex formation between SDN and HSA. Both values of the bimolecular quenching rate constant and UV-Vis absorption spectral results characterized the quenching of HSA fluorescence as static quenching. Analysis of the quenching results showed a moderate binding affinity (Ka = 3.39×104 M‒1 at 300 K) between SDN and HSA. Thermodynamic …
Inhibition Of Biofilm Formation By The Synergistic Action Of Egcg-S And Antibiotics,
2021
Miami University - Oxford
Inhibition Of Biofilm Formation By The Synergistic Action Of Egcg-S And Antibiotics, Shrameeta Shinde, Lee Lee, Tinchun Chu
Department of Biology Faculty Scholarship and Creative Works
Biofilm, a stress-induced physiological state, is an established means of antimicrobial tolerance. A perpetual increase in multidrug resistant (MDR) infections associated with high mortality and morbidity have been observed in healthcare settings. Multiple studies have indicated that the use of natural products can prevent bacterial growth. Recent studies in the field have identified that epigallocatechin gallate (EGCG), a green tea polyphenol, could disrupt bacterial biofilms. A modified lipid-soluble EGCG, epigallocatechin-3-gallate-stearate (EGCG-S), has enhanced the beneficial properties of green tea. This study focuses on utilizing EGCG-S as a novel synergistic agent with antibiotics to prevent or control biofilm. Different formulations of …
Synthesis Of New Anilinoquinazoline Derivatives As Potential Anticancer Agents: Antiproliferative Activity, Molecular Docking And Molecular Dynamics Studies,
2021
Universiti Malaya
Synthesis Of New Anilinoquinazoline Derivatives As Potential Anticancer Agents: Antiproliferative Activity, Molecular Docking And Molecular Dynamics Studies, Muhammad Kumayl Abdul Wahab
Student Works (2020-2029)
Current reversible epidermal growth factor (EGFR) tyrosine kinase inhibitors of the non-small cell lung cancer (NSCLC) have been resisted by T790M mutation, while irreversible inhibitors introduced to overcome the mutation have faced resistance from C797S mutation. In the effort to discover potential reversible EGFR inhibitors, two series of anilinoquinazoline derivatives were synthesized and characterized, studied for their in vitro antiproliferative activity against NSCLC cell lines, namely A549, H1650 and H1975, and studied for the plausible binding mode in epidermal growth factor receptor kinases with different mutations through molecular docking. In the first series, the anilinoquinazoline scaffold was derivatized through the …
Utilization Of The Naranjo Scale To Evaluate Adverse Drug Reactions At A Free-Standing Children's Hospital.,
2021
Children's Mercy Hospital
Utilization Of The Naranjo Scale To Evaluate Adverse Drug Reactions At A Free-Standing Children's Hospital., Madhavi Murali, Sarah Suppes, Keith Feldman, Jennifer Goldman
Manuscripts, Articles, Book Chapters and Other Papers
The relationship between the Naranjo scaling system and pediatric adverse drug reactions (ADR) is poorly understood. We performed a retrospective review of 1,676 pediatric ADRs documented at our hospital from 2014-2018. We evaluated patient demographics, implicated medication, ADR severity, calculated Naranjo score, associated symptoms, and location within the hospital in which the ADR was documented. ADR severity was poorly correlated with Naranjo interpretation. Out of the 10 Naranjo scale questions, 4 had a response of "unknown" greater than 85% of the time. Cardiovascular and oncological/immunologic agents were more likely to have a probable or definite Naranjo interpretation compared to antimicrobials. …
Biosimilars Use In Medicine For Inflammatory Diseases,
2021
Richmond University Medical Center
Biosimilars Use In Medicine For Inflammatory Diseases, Inderbir S. Padda, Rajat Bhatt, Obaid Rehman, Mayur S. Parmar
HPD Articles
No abstract provided.
Upadacitinib,
2021
Richmond University Medical Center
Upadacitinib, Inderbir S. Padda, Rajat Bhatt, Mayur S. Parmar
HPD Articles
No abstract provided.
Tofacitinib,
2021
Richmond University Medical Center
Tofacitinib, Inderbir S. Padda, Rajat Bhatt, Mayur S. Parmar
HPD Articles
No abstract provided.
Anticancer Effect Of Indanone-Based Thiazolyl Hydrazone Derivative On P53 Mutant Colon Cancer Cell Lines: In Vitro And In Vivo Study,
2021
Saint John's University, Jamaica New York
Anticancer Effect Of Indanone-Based Thiazolyl Hydrazone Derivative On P53 Mutant Colon Cancer Cell Lines: In Vitro And In Vivo Study, Silpa Narayanan
Theses and Dissertations
Colorectal cancer is the third leading cause of cancer related deaths in the United States. Currently, irinotecan, a topoisomerase I inhibitor, is an important anticancer drug approved for patients with advanced or recurrent colorectal cancer. Considering the low response rate and the events of high toxicity caused by irinotecan, we evaluated a series of thirteen thiazolyl hydrazone derivatives of 1-indanone for their potential antineoplastic activity and four compounds showed promising anticancer activity against most of the tested colon cancer cell lines with IC50 values ranging from 0.41 ± 0.19 to 6.85 ± 1.44 μM. It is noteworthy that the compound, …
Effect Of Inhibition Of Glycogen Catabolism In Hepatocellular Carcinoma Cells,
2021
Saint John's University, Jamaica New York
Effect Of Inhibition Of Glycogen Catabolism In Hepatocellular Carcinoma Cells, Shrikant Barot
Theses and Dissertations
Metabolic reprogramming is one of the important features of cancers, and there has been growing interest in targeting metabolic proteins to treat cancer. Glycogen is a polymer of glucose and serves as its storage unit in cells. Glycogen can provide energy to cells during the situations of high energy demand. A number of tumors are known to contain high levels of glycogen than their normal tissue counterparts. The liver plays an essential role in maintaining glucose homeostasis in the body via storing it into glycogen. The significance of glycogen metabolism in patients suffering from hepatocellular carcinoma (HCC) has not been …
Boost The Dsicovery Of Mrp7/Abcc10 Substrates And Inhibitors: Establishment Of New In Vitro And In Silico Models,
2021
Saint John's University, Jamaica New York
Boost The Dsicovery Of Mrp7/Abcc10 Substrates And Inhibitors: Establishment Of New In Vitro And In Silico Models, Jingquan Wang
Theses and Dissertations
ATP-binding cassette (ABC) transporters are responsible for the efflux of structurally distinct endo- and xenobiotics energized by ATP hydrolysis. MRP7/ABCC10 belongs to the 10th member of subfamily C and responsible for mediating MDR against a series of chemotherapeutic drugs such as taxanes, epothilones, Vinca alkaloids, anthracyclines and epipodophyllotoxins. Establishment of new in silico and in vitro models for MRP7 substrates/inhibitors prediction Considering the limited knowledge of MRP7, we established a homology model based on bovine MRP1 cryo-EM models. The final model was used for protein global motion analysis and docking analysis. Before docking, potential drug binding pockets were identified and …
Design, Synthesis And Pharmacological Evaluation Of Quinazolinamine Derivatives As Bcrp And P-Gp Inhibitors With Improved Metabolic Stability,
2021
Saint John's University, Jamaica New York
Design, Synthesis And Pharmacological Evaluation Of Quinazolinamine Derivatives As Bcrp And P-Gp Inhibitors With Improved Metabolic Stability, Chao-Yun Cai
Theses and Dissertations
A series of twenty-two quinazolinamine derivatives showing potent inhibitory activities on BCRP and P-gp was synthesized. The reversal study showed that when combined with the potent dual BCRP and P-gp inhibitors 7-8, 29-31, and 34, the IC50 value of mitoxantrone was decreased from 6.50 µM to the range of 0.24 - 0.35 µM for BCRP, and IC50 value of colchicine was decreased from 7.34 μM to the range of 0.12 - 0.29 µM for P-gp. Cyclopropyl quinazolinamine 29 (VKCY-1), which was a dual BCRP and P-gp inhibitor, and azide quinazolinamine 40 (VKCY-2), which was a BCRP inhibitor, were selected for …
Pharmaceuticals In The Environment: Health Implications And Environmental Toxicity,
2021
Wayne State University
Pharmaceuticals In The Environment: Health Implications And Environmental Toxicity, Jessica Phillips
Wayne State University Dissertations
Approximately 2.9 billion prescriptions are written annually in the United States, with a multitude of biochemical actions, with 63151 tons used by food producing animals worldwide and an additional 55-77 million prescriptions written for companion animals. With increasing prescription and unknown toxicologic effects of many of these chemicals, zebrafish (danio rerio), an NIH approved human model, were used to model potentially health effects. Significant abnormalities were seen with extended duration metformin exposure from 4 hours post fertilization up to 5 days post fertilization, although short term metformin exposure for 24 hours at 4-5 days post fertilization did not lead to …
Investigating Lifespan And Legacy Health Effects Of Developmental Exposure To Environmental Toxicants,
2021
Wayne State University
Investigating Lifespan And Legacy Health Effects Of Developmental Exposure To Environmental Toxicants, Danielle Meyer
Wayne State University Dissertations
The environmental presence of toxicants such as persistent organic pollutants, heavy metals, and contaminants of emerging concern is estimated to contribute to over 2 million deaths worldwide and health care costs ranging from ~3-9% of total global expenditures yearly. Many of the above toxicants are classified as endocrine-disrupting chemicals capable of interfering with endogenous hormonal function at environmentally relevant levels. Exposures during sensitive developmental windows can lead to reproductive, neurodevelopmental, and metabolic dysfunction that can last across the lifespan and/or be passed down to future generations. Such long-term effects remain to be well-understood; therefore, we modeled the effects of various …
Science-Based Regulation Of Pharmacological Substances In Competition Horses,
2021
University of Kentucky
Science-Based Regulation Of Pharmacological Substances In Competition Horses, Jacob Machin
Theses and Dissertations--Toxicology and Cancer Biology
Current testing methodologies within equine forensic toxicology focus on arbitrary thresholds and zero-tolerance policy. Modern analytical chemistry’s limits of detection are low enough that oftentimes femtogram-per-milliliter amounts of a substance can readily be identified in both blood and urine of a horse. For most pharmacologically relevant compounds, these concentrations have no relevance to pharmacological effect. It is therefore crucial that testing methodologies to determine appropriate thresholds and cut-offs be developed that are driven by biological activity rather than arbitrary limits of detection. This dissertation looks to address this by suggesting a system of calculated Effective Plasma Concentrations by which a …
Investigation Of Sodium Laurylglucosides Hydroxypropyl Sulfonate Through Response Surface Methodology – Effects Of Amphoteric Surfactant And Electrolyte,
2021
Chulalongkorn University
Investigation Of Sodium Laurylglucosides Hydroxypropyl Sulfonate Through Response Surface Methodology – Effects Of Amphoteric Surfactant And Electrolyte, Phantira Uongpitakpan, Jutarat Kitsongsermthon
The Thai Journal of Pharmaceutical Sciences
The goal of this research was to investigate the effect of electrolyte and an amphoteric surfactant on the viscosity, foamability, and foam stability of sodium laurylglucosides hydroxypropyl sulfonate (SLHS), a new anionic surfactant. Different concentrations of cocamidopropyl betaine (CAPB, 0–6% w/w) and sodium chloride (NaCl, 0–3% w/w) were added into 10% w/w SLHS solution. Each formulation was evaluated for its viscosity using a viscometer, whereas the foamability and foam stability were measured using the cylinder shaking method and analyzed by response surface methodology. The result demonstrated that an increased viscosity of the mixture resulted with an increased NaCl concentration over …
Prospective Process Validation For
The Manufacture Of Ketoprofen Fast
Dissolving Tablets,
2021
Chulalongkorn University
Prospective Process Validation For The Manufacture Of Ketoprofen Fast Dissolving Tablets, Mariam Omari, P. Rashmi, G.S. Shantha Kumar, Pratiksha Patil, Arijit Das
The Thai Journal of Pharmaceutical Sciences
As validation is an integral part of current good manufacturing practice, nowadays, it is practiced in all pharmaceutical industries to assure that the manufacturing process is in control and products of high quality are obtained. Building of quality needs attention in the manufacturing process, from the raw materials to finalized product. The current research work is to perform prospective process validation for the manufacture of ketoprofen fast dissolving tablets (FDT) of 50 mg dose. Various trials and challenge studies were done to finalize critical process parameters. Three consecutive batches of ketoprofen FDT with the same batch size, procedure, equipment, and …
Alpinia Galanga Extract Induces
Senescence In Human Epidermal Growth Factor Receptor 2-Overexpressing Breast Cancer Cells,
2021
Chulalongkorn University
Alpinia Galanga Extract Induces Senescence In Human Epidermal Growth Factor Receptor 2-Overexpressing Breast Cancer Cells, Riris Istighfari Jenie, Ragil Anang Santoso, Irfani Aura Salsabila, Nadzifa Nugraheni, Edy Meiyanto
The Thai Journal of Pharmaceutical Sciences
Background: Alpinia galanga L. (galangal) is a widely known spice in Southeast Asia. A previous study indicated that its active compounds might effectively inhibit (human epidermal growth factor receptor 2 [HER2])-overexpressing breast cancer cell proliferation. Objective: Our study aimed to investigate the antiproliferation activity of galangal extract (GE) on HER2- overexpressing breast cancer cells by analyzing GE cytotoxicity and its mechanism of action. Materials and Methods: We used HCC1954 cell line as a model. We observed the effect of GE (10–200 μg/mL) on cell growth using 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide assay. The modulation of GE on cell cycle, apoptosis, and the intracellular …
Synthesis, In Silico Analysis And
Antidepressant Activity Of Pyrazoline Analogs,
2021
Chulalongkorn University
Synthesis, In Silico Analysis And Antidepressant Activity Of Pyrazoline Analogs, Natasha Naval Aggarwal, Banylla Felicity Dkhar Gatphoh, M. Vijay Kumar, Sawan Ghetia, B. C. Revanasiddappa
The Thai Journal of Pharmaceutical Sciences
Objective: This study is undertaken to design and synthesize new pyrazoline derivatives and to evaluate their antidepressant efficacy by in silico and in vivo studies. Materials and Methods: The title compounds pyrazoline derivatives (PY1-PY9) were yielded by the cyclization of chalcones (C1-C9) with phenylhydrazine HCl in glacial acetic acid. FT-IR, 1H-NMR, and mass spectral data established the structures of the newly synthesized compounds. In silico analysis was carried out using Schrodinger 2018-3 suite device Maestro and docked to the binding site of Human MAO-A enzyme (2Z5X). In vivo antidepressant study was performed by tail suspension method and forced swimming test. …
