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Article: The Role of Point-of-Care Testing to Improve Acute Care and Health Care Services.

Elrobaa, Islam H / Khan, Keebat / Mohamed, Eslam

2024 Volume 16, Issue 3, Page(s) e55315

Abstract: Health care is one of the most important services that need to be provided to any community. Many challenges exist in delivering proper and effective health services, including ensuring timely delivery, providing adequate care through effective ... ...

Abstract	Health care is one of the most important services that need to be provided to any community. Many challenges exist in delivering proper and effective health services, including ensuring timely delivery, providing adequate care through effective management and achieving good outcomes. Point-of-care testing (POCT) plays a crucial role in delivering urgent and appropriate health services, especially in peripheral communities, emergency situations, disaster areas and overcrowded areas. We collected and reviewed secondary data about point-of-care testing from PubMed, Scopus and Google Scholar. Our findings emphasize that POCT provides fast care with minimal waiting time, avoids unnecessary investigations, aids in triage, and provides decision-makers with a clear understanding of the patient's condition to make informed decisions. We recommend point-of-care testing as a frontline investigation in emergency departments, intensive care units, peripheral hospitals, primary health care centers, disaster areas and field hospitals. Point-of-care testing can improve the quality of health services and ensure the provision of necessary health care.
Language	English
Publishing date	2024-03-01
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2747273-5
ISSN	2168-8184
ISSN	2168-8184
DOI	10.7759/cureus.55315
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Article: Maximal Tizanidine withdrawal managed with dexmedetomidine: a vital intervention.

Omer, Marah / Yigit, Yavuz / Alkahlout, Baha Hamdi / Mohamed, Eslam Hussein / Khalil, Sulafa / Azad, Aftab Mohammad

Oxford medical case reports

2024 Volume 2024, Issue 2, Page(s) omae005

Abstract: Tizanidine withdrawal is a rare and complex phenomenon characterized by a surge in adrenergic activity upon abrupt discontinuation of the drug. We present a unique case of a 41-year-old male with multiple comorbidities who self-administered an ... ...

Abstract	Tizanidine withdrawal is a rare and complex phenomenon characterized by a surge in adrenergic activity upon abrupt discontinuation of the drug. We present a unique case of a 41-year-old male with multiple comorbidities who self-administered an exceptionally high daily dose of Tizanidine, leading to severe withdrawal symptoms. This case report highlights the challenges in managing such cases. The patient, with a history of myofascial pain syndrome, hypertension, anxiety, and depression, experienced distressing symptoms, including tachycardia, rebound hypertension, neuropsychiatric manifestations, and involuntary muscle movements. Unlike previous cases, our patient required the addition of dexmedetomidine in conjunction with benzodiazepines for symptom management. Reintroduction of Tizanidine, carefully controlled and tapered, led to stabilization of hemodynamics and cessation of involuntary movements. This case underscores the importance of individualized treatment and vigilant monitoring when dealing with Tizanidine withdrawal, particularly at elevated daily doses.
Language	English
Publishing date	2024-02-16
Publishing country	England
Document type	Case Reports
ZDB-ID	2766251-2
ISSN	2053-8855
ISSN	2053-8855
DOI	10.1093/omcr/omae005
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Article ; Online: Enhancement of Streptomyces thinghirensis WAE1 for production of bioactive metabolites under different optimization strategies.

Osman, Mohamed E / Abo Elnasr, Amany A / Mohamed, Eslam T / Faraag, Ahmed H I

Microbial pathogenesis

2024 Volume 189, Page(s) 106603

Abstract: Isolation of novel bioactive metabolites from Streptomyces strains is a promising source for drug discovery. However, conventional screening approaches have limitations in identifying new leads due to redundant discoveries. Optimization of culture ... ...

Abstract	Isolation of novel bioactive metabolites from Streptomyces strains is a promising source for drug discovery. However, conventional screening approaches have limitations in identifying new leads due to redundant discoveries. Optimization of culture conditions is important but traditionally optimized one factor at a time, failing to consider interactions. This study addressed these gaps by enhancing metabolite production from Streptomyces thinghirensis WAE1 through statistical optimization. Various chemical and physical factors impacting metabolite production were identified. Response surface methodology with a central composite design was applied to optimize significant factors like carbon source, nitrogen source, inoculum size, pH, temperature and incubation period. This optimized production against Streptococcus pneumoniae, increasing antibacterial activity by 74.92%. Gas chromatography-mass spectrometry revealed 19 bioactive compounds, including 1,25-dihydroxyvitamin D3 inhibiting cell wall development. This highlights S. thinghirensis WAE1's potential as a bioresource and emphasizes studying metabolite production from novel Streptomyces strains to discover new antibacterial drugs.
MeSH term(s)	Anti-Bacterial Agents/pharmacology ; Anti-Bacterial Agents/metabolism ; Streptomyces ; Temperature
Chemical Substances	Anti-Bacterial Agents
Language	English
Publishing date	2024-02-28
Publishing country	England
Document type	Journal Article
ZDB-ID	632772-2
ISSN	1096-1208 ; 0882-4010
ISSN (online)	1096-1208
ISSN	0882-4010
DOI	10.1016/j.micpath.2024.106603
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Article ; Online: Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary.

Tsakalozou, Eleftheria / Mohamed, Mohamed-Eslam F / Polak, Sebastian / Heimbach, Tycho

The AAPS journal

2023 Volume 25, Issue 6, Page(s) 96

Abstract: The number of modeling and simulation applications, including physiologically based pharmacokinetic (PBPK) models, physiologically based biopharmaceutics modeling (PBBM), and empirical models, has been constantly increasing along with the regulatory ... ...

Abstract	The number of modeling and simulation applications, including physiologically based pharmacokinetic (PBPK) models, physiologically based biopharmaceutics modeling (PBBM), and empirical models, has been constantly increasing along with the regulatory acceptance of these methodologies. While aiming at minimizing unnecessary human testing, these methodologies are used today to support the development and approval of novel drug products and generics. Modeling approaches are leveraged today for assessing drug-drug interaction, informing dose adjustments in renally or hepatically impaired patients, perform dose selection in pediatrics and pregnant women and diseased populations, and conduct biopharmaceutics-related assessments such as establish clinically relevant specifications for drug products and achieve quality assurance throughout the product life cycle. In the generics space, PBPK analyses are utilized toward virtual bioequivalence assessments within the scope of alternative bioequivalence approaches, product-specific guidance development, and food effect assessments among others. Case studies highlighting the evolving and expanding role of modeling and simulation approaches within the biopharmaceutics space were presented at the symposium titled "Model Informed Drug Development (MIDD): Role in Dose Selection, Vulnerable Populations, and Biowaivers - Chemical Entities" and Prologue "PBPK/PBBM to inform the Bioequivalence Safe Space, Food Effects, and pH-mediated DDIs" at the American Association of Pharmaceutical Scientists (AAPS) PharmSci 360 Annual Meeting in Boston, MA, on October 16-19, 2022, and are summarized here.
MeSH term(s)	Pregnancy ; Humans ; Female ; Child ; Solubility ; Administration, Oral ; Models, Biological ; Drug Development/methods ; Therapeutic Equivalency ; Biopharmaceutics/methods
Language	English
Publishing date	2023-10-02
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	1550-7416
ISSN (online)	1550-7416
DOI	10.1208/s12248-023-00862-x
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Article ; Online: Use of Clinical Trial Simulations to Compare the Performance of Different Approaches for Population Analyses of Pediatric Pharmacokinetic Data.

Temrikar, Zaid / Muensterman, Elena / Engelhardt, Benjamin / Mohamed, Mohamed-Eslam F

Journal of clinical pharmacology

2023 Volume 63, Issue 7, Page(s) 859–868

Abstract: The adequate characterization of the pharmacokinetics of a drug used in pediatrics is a mainstay of pediatric development programs and is critical for accurate dose selection in pediatrics. Analysis approaches can impact the estimation and ... ...

Abstract	The adequate characterization of the pharmacokinetics of a drug used in pediatrics is a mainstay of pediatric development programs and is critical for accurate dose selection in pediatrics. Analysis approaches can impact the estimation and characterization of pediatric pharmacokinetic parameters. Simulations were conducted to compare the performance of different approaches for analyzing pediatric pharmacokinetic data in the presence of extensive data from adult studies. Simulated clinical trial datasets were generated encompassing different scenarios that might be encountered in pediatric drug development. For each scenario, 250 clinical trials were simulated and analyzed using each of the following approaches: (1) estimating pediatric parameters using only pediatric data; (2) fixing specific parameters to adult estimates and estimating the remaining pediatric parameters using only pediatric data; (3) estimating pediatric parameters using adult parameters as informative Bayesian priors; (4) estimating pediatric parameters using combined adult and pediatric datasets with exponents for body weight effects estimated using adult and pediatric data; and (5) estimating pediatric parameters using combined adult and pediatric datasets with exponents for body weight effects estimated using pediatric data only. Each analysis approach was evaluated for its success in the estimation of true pediatric pharmacokinetic parameter values. Results demonstrated that analyzing pediatric data using a Bayesian approach generally performed best and had the lowest probability of significant bias in the estimated pediatric pharmacokinetic parameters among different scenarios evaluated. This clinical trial simulation framework can be used to inform the optimal approach for analyses of pediatric data for other pediatric drug development program scenarios beyond the cases evaluated in these analyses.
MeSH term(s)	Adult ; Child ; Humans ; Bayes Theorem ; Body Weights and Measures ; Computer Simulation ; Drug Development ; Models, Biological
Language	English
Publishing date	2023-05-03
Publishing country	England
Document type	Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	188980-1
ISSN	1552-4604 ; 0091-2700 ; 0021-9754
ISSN (online)	1552-4604
ISSN	0091-2700 ; 0021-9754
DOI	10.1002/jcph.2236
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Article ; Online: Utility of Modeling and Simulation Approach to Support the Clinical Relevance of Dissolution Specifications: a Case Study from Upadacitinib Development.

Mohamed, Mohamed-Eslam F / Winzenborg, Insa / Othman, Ahmed A / Marroum, Patrick

The AAPS journal

2022 Volume 24, Issue 2, Page(s) 39

Abstract: Dissolution specifications are often essential in assuring the quality and consistency of therapeutic benefits of drug lots released to the market as in vitro dissolution is often considered to be a surrogate for bioavailability. Despite the importance ... ...

Abstract	Dissolution specifications are often essential in assuring the quality and consistency of therapeutic benefits of drug lots released to the market as in vitro dissolution is often considered to be a surrogate for bioavailability. Despite the importance of demonstrating the clinical relevance of the dissolution specifications, it is often challenging to achieve this goal. In this case study, a modeling and simulation approach was utilized to support the clinical relevance of the dissolution specifications for upadacitinib extended-release tablets. A level A in vitro in vivo correlation was developed and utilized in predicting upadacitinib plasma exposures for formulations which correspond to the upper and lower dissolution limits. Exposure-response models for upadacitinib efficacy and safety in patients with moderate to severe rheumatoid arthritis (RA) were utilized to conduct clinical trial simulations to evaluate the efficacy and safety of formulations at the upper and lower dissolution boundaries. Each simulated clinical trial consisted of three treatment arms: (1) upadacitinib 15 mg QD using the target formulation, (2) upadacitinib 15 mg QD using a formulation at the lower dissolution boundary, and (3) upadacitinib 15 mg QD using a formulation at the upper dissolution boundary. Each simulated trial included 300 patients per arm and simulations were replicated 200 times. Results demonstrated that formulations at the lower and upper dissolution boundaries are predicted to have noninferior efficacy and comparable safety to the target 15 mg extended-release formulation. This approach was successfully utilized in demonstrating the clinical relevance of upadacitinib extended-release tablet dissolution specifications. Graphical Abstract.
MeSH term(s)	Arthritis, Rheumatoid/drug therapy ; Clinical Trials as Topic ; Heterocyclic Compounds, 3-Ring/adverse effects ; Humans ; Solubility ; Tablets/therapeutic use
Chemical Substances	Heterocyclic Compounds, 3-Ring ; Tablets ; upadacitinib (4RA0KN46E0)
Language	English
Publishing date	2022-03-01
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	1550-7416
ISSN (online)	1550-7416
DOI	10.1208/s12248-022-00681-6
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Article ; Online: Are the outcomes of single-stage open reduction and Dega osteotomy the same when treating DDH in patients younger than 8 years old? A prospective cohort study.

Zein, AboBakr / Khalifa, Ahmed A / Elsherif, Mohamed Eslam / Elbarbary, Hassan / Badaway, Mohamed Youness

Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology

2023 Volume 24, Issue 1, Page(s) 43

MeSH term(s)	Humans ; Infant ; Child, Preschool ; Child ; Prospective Studies ; Acetabulum/diagnostic imaging ; Acetabulum/surgery ; Femur ; Operative Time ; Osteotomy
Language	English
Publishing date	2023-08-17
Publishing country	Italy
Document type	Journal Article
ZDB-ID	2043336-0
ISSN	1590-9999 ; 1590-9921
ISSN (online)	1590-9999
ISSN	1590-9921
DOI	10.1186/s10195-023-00725-3
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Article ; Online: Upadacitinib: Mechanism of action, clinical, and translational science.

Mohamed, Mohamed-Eslam F / Bhatnagar, Sumit / Parmentier, Julie M / Nakasato, Priscila / Wung, Peter

Clinical and translational science

2023 Volume 17, Issue 1, Page(s) e13688

Abstract: Upadacitinib is a selective Janus kinase (JAK) inhibitor which is approved by the US Food and Drug Administration, the European Medicines Agency, as well as other agencies around the world for the treatment of several chronic inflammatory diseases, ... ...

Abstract	Upadacitinib is a selective Janus kinase (JAK) inhibitor which is approved by the US Food and Drug Administration, the European Medicines Agency, as well as other agencies around the world for the treatment of several chronic inflammatory diseases, including rheumatic, dermatologic, and gastrointestinal diseases. Through inhibition of JAK, upadacitinib inhibits phosphorylation of downstream effector proteins, which consequently inhibits cytokine signaling for key pathways involved in inflammatory diseases. Upadacitinib more potently inhibits JAK1 than other JAK isoforms. The pharmacokinetics, pharmacodynamics, efficacy, and safety of upadacitinib were characterized in many clinical trials, which demonstrated the superiority of upadacitinib treatment over placebo or an active comparator in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, atopic dermatitis, Crohn's disease, and ulcerative colitis. The safety profile of upadacitinib supported a favorable benefit-risk profile across all the approved indications. In this article, we review the mechanism of action of upadacitinib and describe how the JAK-STAT (Janus kinase-signal transducers and activators of transcription) pathway is involved in the pathogenesis of several chronic and progressive immune-mediated inflammatory diseases. In addition, this review also provides an overview of key clinical trials that were conducted as well as relevant data which supported the clinical development of upadacitinib and informed the recommended dose(s) in each of the approved indications.
MeSH term(s)	United States ; Humans ; Translational Science, Biomedical ; Arthritis, Rheumatoid/drug therapy ; Spondylitis, Ankylosing/drug therapy ; Janus Kinase Inhibitors/therapeutic use ; Janus Kinases/therapeutic use ; Heterocyclic Compounds, 3-Ring
Chemical Substances	upadacitinib (4RA0KN46E0) ; Janus Kinase Inhibitors ; Janus Kinases (EC 2.7.10.2) ; Heterocyclic Compounds, 3-Ring
Language	English
Publishing date	2023-12-18
Publishing country	United States
Document type	Journal Article ; Review ; Research Support, Non-U.S. Gov't
ZDB-ID	2433157-0
ISSN	1752-8062 ; 1752-8054
ISSN (online)	1752-8062
ISSN	1752-8054
DOI	10.1111/cts.13688
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Article ; Online: Population pharmacokinetics and exposure-response analyses for efficacy and safety of upadacitinib in patients with axial spondyloarthritis.

Bhatnagar, Sumit / Eckert, Doerthe / Stodtmann, Sven / Song, In-Ho / Wung, Peter / Liu, Wei / Mohamed, Mohamed-Eslam F

Clinical and translational science

2024 Volume 17, Issue 2, Page(s) e13733

Abstract: Upadacitinib is an orally administered, selective, Janus kinase inhibitor that is approved for several auto-immune conditions, such as axial spondyloarthritis, an inflammatory rheumatic disease that includes ankylosing spondylitis (AS) and non- ... ...

Abstract	Upadacitinib is an orally administered, selective, Janus kinase inhibitor that is approved for several auto-immune conditions, such as axial spondyloarthritis, an inflammatory rheumatic disease that includes ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). The approvals of upadacitinib for the treatment of AS and nr-axSpA were based on the safety and efficacy data for upadacitinib 15 mg once-daily compared to placebo from the SELECT-AXIS 1 and SELECT-AXIS 2 studies. Population pharmacokinetic analyses based on data from 244 patients with axSpA showed that the pharmacokinetics of upadacitinib were comparable in subjects with AS and nr-axSpA. Exposure-response relationships were characterized for key efficacy and safety end points using data from 482 patients with axSpA. The exposure-response analyses for efficacy based on Assessment of SpondyloArthritis International Society (ASAS)20 and ASAS40 responses at week 14, showed a clear differentiation from placebo with no evidence of increased responses with increasing upadacitinib plasma exposures. There were no clear exposure-response trends observed for safety end points that included serious infections, herpes zoster, pneumonia, lymphopenia (grade ≥3), neutropenia (grade ≥3), or a greater than 2 g/dL decrease in hemoglobin from baseline through week 14. The exposure-response analyses for efficacy and safety presented here supported the favorable benefit-risk profile with the use of upadacitinib 15 mg once-daily for the treatment of axSpA.
MeSH term(s)	Humans ; Antirheumatic Agents/therapeutic use ; Non-Radiographic Axial Spondyloarthritis ; Spondylitis, Ankylosing/drug therapy ; Spondylarthritis/drug therapy
Chemical Substances	Antirheumatic Agents
Language	English
Publishing date	2024-04-04
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2433157-0
ISSN	1752-8062 ; 1752-8054
ISSN (online)	1752-8062
ISSN	1752-8054
DOI	10.1111/cts.13733
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Article ; Online: Cedirogant Population Pharmacokinetics and Pharmacodynamic Analyses of Interleukin-17A Inhibition in Two Phase 1 Studies in Healthy Participants and Participants with Moderate to Severe Psoriasis.

Maier, Corinna S / Eckert, Doerthe / Laroux, F Stephen / Hew, Kinjal M / Suleiman, Ahmed A / Liu, Wei / Mohamed, Mohamed-Eslam F

Clinical pharmacology in drug development

2024 Volume 13, Issue 5, Page(s) 474–484

Abstract: Cedirogant (ABBV-157) is an orally bioavailable inverse agonist of retinoic acid-related orphan receptor gamma thymus. Data from 2 Phase 1 studies were used to characterize cedirogant pharmacokinetics and evaluate target engagement. Cedirogant plasma ... ...

Abstract	Cedirogant (ABBV-157) is an orally bioavailable inverse agonist of retinoic acid-related orphan receptor gamma thymus. Data from 2 Phase 1 studies were used to characterize cedirogant pharmacokinetics and evaluate target engagement. Cedirogant plasma concentrations and ex vivo interleukin 17A (IL-17A) concentrations from healthy participants and participants with moderate to severe psoriasis (PsO) were analyzed in a population pharmacokinetic and pharmacodynamic modeling framework to characterize cedirogant pharmacokinetics following single and multiple doses and assess ex vivo IL-17A inhibition in relation to cedirogant exposure. Cedirogant population pharmacokinetics were best described by a 2-compartment pharmacokinetic model with delayed absorption and an enzyme turnover compartment to describe cytochrome P450 3A autoinduction. The pharmacokinetics of cedirogant were comparable between healthy participants and participants with PsO. Cedirogant steady-state average and maximum plasma concentrations were predicted to be 7.56 and 11.8 mg/L, respectively, for participants with PsO for the 375 mg once-daily regimen on Day 14. The apparent clearance and apparent volume of distribution for cedirogant were estimated to be 24.5 L/day and 28.2 L, respectively. A direct maximum inhibition model adequately characterized the exposure-response relationship of cedirogant and ex vivo IL-17A inhibition, indicating no temporal delay between exposure and response with a saturable inhibition of IL-17A. Model-estimated half-maximal inhibitory concentration and maximum inhibition values for cedirogant inhibition of ex vivo IL-17A were 0.56 mg/L and 0.76, respectively. The established relationship between cedirogant exposure and biomarker effect supported dose selection for the Phase 2 dose-ranging study in patients with PsO.
MeSH term(s)	Adult ; Female ; Humans ; Male ; Middle Aged ; Young Adult ; Administration, Oral ; Double-Blind Method ; Healthy Volunteers ; Interleukin-17/antagonists & inhibitors ; Interleukin-17/blood ; Models, Biological ; Psoriasis/drug therapy ; Severity of Illness Index
Chemical Substances	IL17A protein, human ; Interleukin-17
Language	English
Publishing date	2024-01-17
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2649010-9
ISSN	2160-7648 ; 2160-763X
ISSN (online)	2160-7648
ISSN	2160-763X
DOI	10.1002/cpdd.1377
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