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  1. Article ; Online: Pharmaceutical Quality, Team Science, and Education Themes: Observations and Commentary on a Remarkable AAPS PharmSciTech Theme Issue.

    Hussain, Ajaz S / Morris, Kenneth / Gurvich, Vadim J

    AAPS PharmSciTech

    2021  Volume 22, Issue 3, Page(s) 88

    Language English
    Publishing date 2021-03-04
    Publishing country United States
    Document type Editorial
    ZDB-ID 2052070-0
    ISSN 1530-9932 ; 1530-9932
    ISSN (online) 1530-9932
    ISSN 1530-9932
    DOI 10.1208/s12249-021-01970-7
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: In and Beyond COVID-19: US Academic Pharmaceutical Science and Engineering Community Must Engage to Meet Critical National Needs.

    Gurvich, Vadim J / Hussain, Ajaz S

    AAPS PharmSciTech

    2020  Volume 21, Issue 5, Page(s) 153

    Abstract: The supply of affordable, high-quality pharmaceuticals to US patients has been on a critical path for decades. In and beyond the COVID-19 pandemic, this critical path has become tortuous. To regain reliability, reshoring of the pharmaceutical supply ... ...

    Abstract The supply of affordable, high-quality pharmaceuticals to US patients has been on a critical path for decades. In and beyond the COVID-19 pandemic, this critical path has become tortuous. To regain reliability, reshoring of the pharmaceutical supply chain to the USA is now a vital national security need. Reshoring the pharmaceutical supply with old know-how and outdated technologies that cause inherent unpredictability and adverse environmental impact will neither provide the security we seek nor will it be competitive and affordable. The challenge at hand is complex akin to redesigning systems, including corporate and public research and development, manufacturing, regulatory, and education ones. The US academic community must be engaged in progressing solutions needed to counter emergencies in the COVID-19 pandemic and in building new methods to reshore the pharmaceutical supply chain beyond the pandemic.
    MeSH term(s) Antiviral Agents/economics ; Antiviral Agents/supply & distribution ; Betacoronavirus/drug effects ; Betacoronavirus/pathogenicity ; COVID-19 ; COVID-19 Vaccines ; Civil Defense/economics ; Civil Defense/organization & administration ; Coronavirus Infections/drug therapy ; Coronavirus Infections/economics ; Coronavirus Infections/epidemiology ; Coronavirus Infections/prevention & control ; Coronavirus Infections/therapy ; Coronavirus Infections/virology ; Drug Costs ; Health Services Needs and Demand/economics ; Health Services Needs and Demand/organization & administration ; Humans ; Needs Assessment/economics ; Needs Assessment/organization & administration ; Pandemics/economics ; Pneumonia, Viral/economics ; Pneumonia, Viral/epidemiology ; Pneumonia, Viral/therapy ; Pneumonia, Viral/virology ; SARS-CoV-2 ; United States ; Viral Vaccines/economics ; Viral Vaccines/supply & distribution
    Chemical Substances Antiviral Agents ; COVID-19 Vaccines ; Viral Vaccines
    Keywords covid19
    Language English
    Publishing date 2020-05-24
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2052070-0
    ISSN 1530-9932 ; 1530-9932
    ISSN (online) 1530-9932
    ISSN 1530-9932
    DOI 10.1208/s12249-020-01718-9
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: In and Beyond COVID-19

    Gurvich, Vadim J. / Hussain, Ajaz S.

    AAPS PharmSciTech

    US Academic Pharmaceutical Science and Engineering Community Must Engage to Meet Critical National Needs

    2020  Volume 21, Issue 5

    Keywords Agronomy and Crop Science ; Ecology ; Aquatic Science ; Ecology, Evolution, Behavior and Systematics ; Drug Discovery ; Pharmaceutical Science ; General Medicine ; covid19
    Language English
    Publisher Springer Science and Business Media LLC
    Publishing country us
    Document type Article ; Online
    ZDB-ID 2052070-0
    ISSN 1530-9932
    ISSN 1530-9932
    DOI 10.1208/s12249-020-01718-9
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article: In and Beyond COVID-19: US Academic Pharmaceutical Science and Engineering Community Must Engage to Meet Critical National Needs

    Gurvich, Vadim J / Hussain, Ajaz S

    AAPS PharmSciTech

    Abstract: The supply of affordable, high-quality pharmaceuticals to US patients has been on a critical path for decades. In and beyond the COVID-19 pandemic, this critical path has become tortuous. To regain reliability, reshoring of the pharmaceutical supply ... ...

    Abstract The supply of affordable, high-quality pharmaceuticals to US patients has been on a critical path for decades. In and beyond the COVID-19 pandemic, this critical path has become tortuous. To regain reliability, reshoring of the pharmaceutical supply chain to the USA is now a vital national security need. Reshoring the pharmaceutical supply with old know-how and outdated technologies that cause inherent unpredictability and adverse environmental impact will neither provide the security we seek nor will it be competitive and affordable. The challenge at hand is complex akin to redesigning systems, including corporate and public research and development, manufacturing, regulatory, and education ones. The US academic community must be engaged in progressing solutions needed to counter emergencies in the COVID-19 pandemic and in building new methods to reshore the pharmaceutical supply chain beyond the pandemic.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #343702
    Database COVID19

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  5. Article ; Online: Pharmaceutical "New Prior Knowledge": Twenty-First Century Assurance of Therapeutic Equivalence.

    Hussain, Ajaz S / Gurvich, Vadim J / Morris, Kenneth

    AAPS PharmSciTech

    2019  Volume 20, Issue 3, Page(s) 140

    Abstract: Facilitating utility of prior knowledge to accelerate evidence-based new drug development is a focus of several communities of knowledge, such as clinical pharmacology. For example, progress has been made via modeling and simulation of pharmacokinetic ... ...

    Abstract Facilitating utility of prior knowledge to accelerate evidence-based new drug development is a focus of several communities of knowledge, such as clinical pharmacology. For example, progress has been made via modeling and simulation of pharmacokinetic and pharmacodynamic relationships in the more effective use of "End of Phase 2" regulatory meetings for a New Drug Application (NDA). Facilitating utility of prior "Chemistry, Manufacturing, and Controls" (CMC) knowledge to accelerate new drug development and regulatory review process is also a topic of significant interest. This paper focuses on facilitating the utility of prior pharmaceutical formulation knowledge to accelerate drug product development and regulatory review of generic and biosimilar products. This knowledge is described as New Prior Knowledge (NPK) because research is often needed to fill ontological (i.e., the domain of connectivity between concepts and phenomena), epistemological (i.e., distinguishing knowledge or justified belief from the opinion), and methodological gaps in information derived a decade or so ago. The corporate economic advantages of such knowledge are derived, in part, when significant portions remain a trade secret. The proposed NPK seeks to generate knowledge about critical aspects of pharmaceutical quality and failure modes to place it in the public domain and to facilitate accelerated and more confident development and regulatory review of generic products. The paradoxical combination of "new" and "prior knowledge" is chosen deliberately to highlight both a distinction from proprietary and trade secret information and to acknowledge certain historical dogmas inherent in the current practices. Considerations for operationalizing NPK are also summarized.
    MeSH term(s) Administration, Intranasal ; Biosimilar Pharmaceuticals ; Drug Development ; Drugs, Generic ; Enoxaparin/administration & dosage ; Humans ; Mometasone Furoate/administration & dosage ; Pharmaceutical Preparations ; Therapeutic Equivalency ; Thyroxine/administration & dosage
    Chemical Substances Biosimilar Pharmaceuticals ; Drugs, Generic ; Enoxaparin ; Pharmaceutical Preparations ; Mometasone Furoate (04201GDN4R) ; Thyroxine (Q51BO43MG4)
    Language English
    Publishing date 2019-03-12
    Publishing country United States
    Document type Journal Article
    ISSN 1530-9932
    ISSN (online) 1530-9932
    DOI 10.1208/s12249-019-1347-6
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: NIPTE: a multi-university partnership supporting academic drug development.

    Gurvich, Vadim J / Byrn, Stephen R

    Drug discovery today

    2013  Volume 18, Issue 19-20, Page(s) 916–921

    Abstract: The strategic goal of academic translational research is to accelerate translational science through the improvement and development of resources for moving discoveries across translational barriers through 'first in humans' studies. To achieve this goal, ...

    Abstract The strategic goal of academic translational research is to accelerate translational science through the improvement and development of resources for moving discoveries across translational barriers through 'first in humans' studies. To achieve this goal, access to drug discovery resources and preclinical IND-enabling infrastructure is crucial. One potential approach of research institutions for coordinating preclinical development, based on a model from the National Institute for Pharmaceutical Technology and Education (NIPTE), can provide academic translational and medical centers with access to a wide variety of enabling infrastructure for developing small molecule clinical candidates in an efficient, cost-effective manner.
    MeSH term(s) Academic Medical Centers/economics ; Academic Medical Centers/trends ; Academies and Institutes/economics ; Academies and Institutes/trends ; Animals ; Drug Discovery/economics ; Drug Discovery/trends ; Humans ; Technology, Pharmaceutical/economics ; Technology, Pharmaceutical/trends ; Translational Medical Research/economics ; Translational Medical Research/trends ; Universities/economics ; Universities/trends
    Language English
    Publishing date 2013-10
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 1324988-5
    ISSN 1878-5832 ; 1359-6446
    ISSN (online) 1878-5832
    ISSN 1359-6446
    DOI 10.1016/j.drudis.2013.05.014
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

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  7. Article ; Online: A novel drug-like water-soluble small molecule Focal Adhesion Kinase (FAK) activator promotes intestinal mucosal healing.

    Wang, Qinggang / Gallardo-Macias, Ricardo / Vomhof-DeKrey, Emilie E / Gupta, Rashmi / Golovko, Svetlana A / Golovko, Mikhail Y / Oncel, Sema / Gurvich, Vadim J / Basson, Marc D

    Current research in pharmacology and drug discovery

    2022  Volume 4, Page(s) 100147

    Abstract: Non-steroidal anti-inflammatory drugs (NSAIDs) injure the proximal and distal gut by different mechanisms. While many drugs reduce gastrointestinal injury, no drug directly stimulates mucosal wound healing. Focal adhesion kinase (FAK), a non-receptor ... ...

    Abstract Non-steroidal anti-inflammatory drugs (NSAIDs) injure the proximal and distal gut by different mechanisms. While many drugs reduce gastrointestinal injury, no drug directly stimulates mucosal wound healing. Focal adhesion kinase (FAK), a non-receptor tyrosine kinase, induces epithelial sheet migration. We synthesized and evaluated a water-soluble FAK-activating small molecule, M64HCl, with drug-like properties. Monolayer wound closure and Western blots measured migration and FAK phosphorylation in Caco-2 ​cells, in vitro kinase assays established FAK activation, and pharmacologic tests assessed drug-like properties. 30 ​mg/kg/day M64HCl was administered in two murine small intestine injury models for 4 days. M64HCl (0.1-1000 ​nM) dose-dependently increased Caco-2 FAK-Tyr 397 phosphorylation, without activating Pyk2 and accelerated Caco-2 monolayer wound closure. M64HCl dose-responsively activates the FAK kinase domain vs. the non-salt M64, increasing the V
    Language English
    Publishing date 2022-12-23
    Publishing country Netherlands
    Document type Journal Article
    ISSN 2590-2571
    ISSN (online) 2590-2571
    DOI 10.1016/j.crphar.2022.100147
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  8. Article ; Online: Physical Barrier Type Abuse-Deterrent Formulations: Mechanistic Understanding of Sintering-Induced Microstructural Changes in Polyethylene Oxide Placebo Tablets.

    Boyce, Heather J / Dave, Vivek S / Scoggins, Myke / Gurvich, Vadim J / Smith, Daniel T / Byrn, Stephen R / Hoag, Stephen W

    AAPS PharmSciTech

    2020  Volume 21, Issue 3, Page(s) 86

    Abstract: The main goal of the presented work was to understand changes in the microstructure of tablets, as well as the properties of its main component viz. polyethylene oxide (PEO) as a function of sintering. Key polymer variables and sintering conditions were ... ...

    Abstract The main goal of the presented work was to understand changes in the microstructure of tablets, as well as the properties of its main component viz. polyethylene oxide (PEO) as a function of sintering. Key polymer variables and sintering conditions were investigated, and sintering-induced increase in tablet tensile strength was evaluated. For the current study, binary-component placebo tablets comprised of varying ratios of PEO and anhydrous dibasic calcium phosphate (DCP) were prepared at two levels of tablet solid fraction. The prepared tablets were sintered in an oven at 80°C at different time points ranging from 10 to 900 min and were evaluated for pore size, tablet expansion (%), and PEO crystallinity. The results showed that for efficient sintering and a significant increase in the tablet tensile strength, a minimum of 50% w/w PEO was required. Moreover, all microstructural changes in tablets were found to occur within 60 min of sintering, with no significant changes occurring thereafter. Sintering also resulted in a decrease in PEO crystallinity, causing changes in polymer ductility. These changes in PEO ductility resulted in tablets with higher tensile strength. Formulation variables such as PEO level and PEO particle size distribution were found to be important influencers of the sintering process. Additionally, tablets with high initial solid fraction and sintering duration of 60 min were found to be optimal conditions for efficient sintering of PEO-based compacts. Finally, prolonged sintering times were not found to provide any additional benefits in terms of abuse-deterrent properties.
    MeSH term(s) Abuse-Deterrent Formulations ; Polyethylene Glycols/chemistry ; Tablets/chemistry ; Tensile Strength
    Chemical Substances Abuse-Deterrent Formulations ; Tablets ; Polyethylene Glycols (3WJQ0SDW1A)
    Language English
    Publishing date 2020-01-29
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2052070-0
    ISSN 1530-9932 ; 1530-9932
    ISSN (online) 1530-9932
    ISSN 1530-9932
    DOI 10.1208/s12249-019-1594-6
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article: Discovery of Novel Small-Molecule FAK Activators Promoting Mucosal Healing.

    Wang, Qinggang / Gallardo-Macias, Ricardo / Rashmi / Golovko, Mikhail Y / Elsayed, Ahmed Adham Raafat / More, Shyam K / Oncel, Sema / Gurvich, Vadim J / Basson, Marc D

    ACS medicinal chemistry letters

    2021  Volume 12, Issue 3, Page(s) 356–364

    Abstract: Gastrointestinal mucosal wounds are common to patients injured by factors as diverse as drugs, inflammatory bowel disease, peptic ulcers, and necrotizing enterocolitis. However, although many drugs are used to ameliorate injurious factors, there is no ... ...

    Abstract Gastrointestinal mucosal wounds are common to patients injured by factors as diverse as drugs, inflammatory bowel disease, peptic ulcers, and necrotizing enterocolitis. However, although many drugs are used to ameliorate injurious factors, there is no drug available to actually stimulate mucosal wound healing. Focal adhesion kinase (FAK), a nonreceptor tyrosine kinase, induces epithelial sheet migration and wound healing, making FAK a potential pharmacological target in this regard. In our previous research, we found a lead compound with drug-like properties, ZINC40099027, which promotes FAK phosphorylation, inducing mucosal healing in murine models. Herein we describe the design and optimization of a small library of novel FAK activators based on ZINC40099027 and their applications toward human intestinal epithelial wound closure and mouse ulcer healing.
    Language English
    Publishing date 2021-02-16
    Publishing country United States
    Document type Journal Article
    ISSN 1948-5875
    ISSN 1948-5875
    DOI 10.1021/acsmedchemlett.0c00311
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  10. Article ; Online: In Vitro Assessment of Nasal Insufflation of Comminuted Drug Products Designed as Abuse Deterrent Using the Vertical Diffusion Cell.

    Boyce, Heather / Smith, Dan / Byrn, Steve / Saluja, Bhawana / Qu, Wen / Gurvich, Vadim J / Hoag, Stephen W

    AAPS PharmSciTech

    2018  Volume 19, Issue 4, Page(s) 1744–1757

    Abstract: In vitro evaluation of abuse deterrent formulations (ADFs) is a challenge since real abuse situations are variable and ADF technology is evolving. Specifically, an assessment of an ADF to deter nasal insufflation would be valuable. In this study, a ... ...

    Abstract In vitro evaluation of abuse deterrent formulations (ADFs) is a challenge since real abuse situations are variable and ADF technology is evolving. Specifically, an assessment of an ADF to deter nasal insufflation would be valuable. In this study, a vertical diffusion cell (VDC) was used to evaluate polyethylene oxide (PEO)-based tablets manipulated by three different forces. The commercially available products Oxycontin®, an ADF, Opana®, and metoprolol tartrate tablet formulations made in our laboratory were studied. Particle size distribution and percent recovery of manipulated tablets were measured. Grinding produced the lowest recovery and the smallest particle size distribution. Drug release was examined using a VDC by placing the dry comminuted particles on an enclosed wetted cellulose membrane. Dispensing dry particles on a VDC is atypical but includes some key features associated with an abuse situation where once the particles are snorted, the moisture in the nasal mucosa activates hydration and swelling of the polymers in the formulation, retarding drug release. Drug release from OxyContin®, Opana®, and metoprolol tablets were analyzed for the cutting, grinding, and milling modes of abuse. The analysis showed that in most cases, the mode of abuse produced different particle sizes with different release rates. Statistically different release rates were observed for metoprolol tablets made with different molecular weight PEO and with different porosities. These results indicate that within detection limits, the VDC can be used to quantitate release differences due to various modes of abuse used in this study.
    MeSH term(s) Administration, Intranasal ; Analgesics, Opioid/administration & dosage ; Analgesics, Opioid/metabolism ; Delayed-Action Preparations/administration & dosage ; Delayed-Action Preparations/chemistry ; Delayed-Action Preparations/metabolism ; Diffusion/drug effects ; Drug Liberation/physiology ; Humans ; Insufflation/methods ; Particle Size ; Substance-Related Disorders/metabolism ; Substance-Related Disorders/prevention & control ; Tablets
    Chemical Substances Analgesics, Opioid ; Delayed-Action Preparations ; Tablets
    Language English
    Publishing date 2018-03-26
    Publishing country United States
    Document type Journal Article
    ISSN 1530-9932
    ISSN (online) 1530-9932
    DOI 10.1208/s12249-017-0947-2
    Database MEDical Literature Analysis and Retrieval System OnLINE

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