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  1. Article ; Online: Near- and forecasting the SARS-COV-2 epidemic requires a global view and multiple methods

    Austin, Daren J

    Abstract: Conventional epidemiological models require estimates of important parameters including incubation time and case fatality rate that may be unavailable in the early stage of an epidemic. For the ongoing SARS-COV-2 epidemic, with no previous population ... ...

    Abstract Conventional epidemiological models require estimates of important parameters including incubation time and case fatality rate that may be unavailable in the early stage of an epidemic. For the ongoing SARS-COV-2 epidemic, with no previous population exposure, alternative prediction methods less reliant on assumptions may prove more effective in the near-term. We present three methods used to provide early estimates of likely SARS-COV-2 epidemic progression. During the first stage of the epidemic, growth rate charts revealed the UK, Italy and Spain as outliers, with differentially increasing growth of deaths over cases. A novel data-driven time-series model was then used to near-cast 7-day future cases and deaths with much greater precision. Finally, an epidemio-statistical model was used to bridge from near-casting to forecasting the future course of the global epidemic. By applying multiple approaches to global SARS-COV-2 data, coupled with mixed-effects methods, countries further ahead in the epidemic provide valuable information for those behind. Using current daily global data, we note convergence in near-term predictions for Italy signifying an appropriate call on the future course of the global epidemic. For the UK and elsewhere, prediction of peak and eventual time to resolution is now possible.
    Keywords covid19
    Publisher MedRxiv; WHO
    Document type Article ; Online
    Note WHO #Covidence: #20059402
    DOI 10.1101/2020.04.09.20059402
    Database COVID19

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  2. Article ; Online: Near- and forecasting the SARS-COV-2 epidemic requires a global view and multiple methods

    Austin, Daren J

    medRxiv

    Abstract: Conventional epidemiological models require estimates of important parameters including incubation time and case fatality rate that may be unavailable in the early stage of an epidemic. For the ongoing SARS-COV-2 epidemic, with no previous population ... ...

    Abstract Conventional epidemiological models require estimates of important parameters including incubation time and case fatality rate that may be unavailable in the early stage of an epidemic. For the ongoing SARS-COV-2 epidemic, with no previous population exposure, alternative prediction methods less reliant on assumptions may prove more effective in the near-term. We present three methods used to provide early estimates of likely SARS-COV-2 epidemic progression. During the first stage of the epidemic, growth rate charts revealed the UK, Italy and Spain as outliers, with differentially increasing growth of deaths over cases. A novel data-driven time-series model was then used to near-cast 7-day future cases and deaths with much greater precision. Finally, an epidemio-statistical model was used to bridge from near-casting to forecasting the future course of the global epidemic. By applying multiple approaches to global SARS-COV-2 data, coupled with mixed-effects methods, countries further ahead in the epidemic provide valuable information for those behind. Using current daily global data, we note convergence in near-term predictions for Italy signifying an appropriate call on the future course of the global epidemic. For the UK and elsewhere, prediction of peak and eventual time to resolution is now possible.
    Keywords covid19
    Language English
    Publishing date 2020-04-14
    Publisher Cold Spring Harbor Laboratory Press
    Document type Article ; Online
    DOI 10.1101/2020.04.09.20059402
    Database COVID19

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  3. Article ; Online: Evaluation of Potential Therapeutic Options for COVID-19.

    Austin, Daren / Okour, Malek

    Journal of clinical pharmacology

    2020  Volume 60, Issue 8, Page(s) 976–977

    MeSH term(s) Antiviral Agents/administration & dosage ; Antiviral Agents/pharmacokinetics ; Antiviral Agents/therapeutic use ; Betacoronavirus/drug effects ; COVID-19 ; Coronavirus Infections/drug therapy ; Dose-Response Relationship, Drug ; Humans ; Pandemics ; Pneumonia, Viral/drug therapy ; SARS-CoV-2
    Chemical Substances Antiviral Agents
    Keywords covid19
    Language English
    Publishing date 2020-07-08
    Publishing country England
    Document type Letter
    ZDB-ID 188980-1
    ISSN 1552-4604 ; 0091-2700 ; 0021-9754
    ISSN (online) 1552-4604
    ISSN 0091-2700 ; 0021-9754
    DOI 10.1002/jcph.1669
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  5. Article ; Online: Population Dose-Response-Time Analysis of Itch Reduction and Patient-Reported Tolerability Supports Phase III Dose Selection for Linerixibat.

    Carreño, Fernando / Karatza, Eleni / Mehta, Rashmi / Collins, Jon / Austin, Daren / Swift, Brandon

    Clinical pharmacology and therapeutics

    2023  Volume 115, Issue 2, Page(s) 288–298

    Abstract: Increase in serum bile acids (BAs) in patients with primary biliary cholangitis (PBC) may play a causal role in cholestatic pruritus (itch). Linerixibat is a selective small molecule inhibitor of the ileal bile acid transporter, which blocks re- ... ...

    Abstract Increase in serum bile acids (BAs) in patients with primary biliary cholangitis (PBC) may play a causal role in cholestatic pruritus (itch). Linerixibat is a selective small molecule inhibitor of the ileal bile acid transporter, which blocks re-absorption of BAs in the gastrointestinal tract thereby lowering BAs in the systemic circulation and reducing itch. One consequence is excess BAs in the colon, leading to diarrhea and abdominal pain. GLIMMER (NCT02966834) was a placebo-controlled phase IIb dose-ranging trial of linerixibat once (q.d.) or twice daily (b.i.d.) in adults with moderate to severe pruritus and PBC. To determine the optimal dose for maximum itch reduction while minimizing diarrhea, a kinetic-pharmacodynamic (k-PD) model was developed using data from GLIMMER. The PD end point modeled was worst daily itch, derived from itch score reported by patients b.i.d. A proportional odds model was developed post hoc to indicate the probability of diarrhea occurrence, a patient-reported outcome (GI-5) recorded weekly. The final k-PD model successfully described the effects of linerixibat and placebo on itch. Model simulations were consistent with the observed dose-dependent increase in the average number of itch responders (patients with a ≥ 2-point improvement in itch). This was paralleled by a dose-dependent increase in the probability of higher diarrhea frequency scores. The b.i.d. dosing regimens led to a modest increase in the number of itch responders as compared with q.d. dosing. This quantitative framework highlights the trade-off between benefit and tolerability and supported the selection of 40 mg b.i.d. in the phase III GLISTEN trial (NCT04950127).
    MeSH term(s) Adult ; Humans ; Clinical Protocols ; Diarrhea/chemically induced ; Diarrhea/drug therapy ; Gastrointestinal Tract ; Patient Reported Outcome Measures ; Pruritus/drug therapy
    Language English
    Publishing date 2023-12-03
    Publishing country United States
    Document type Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 123793-7
    ISSN 1532-6535 ; 0009-9236
    ISSN (online) 1532-6535
    ISSN 0009-9236
    DOI 10.1002/cpt.3103
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  6. Article ; Online: Evaluation of Potential Therapeutic Options for COVID‐19

    Austin, Daren / Okour, Malek

    The Journal of Clinical Pharmacology

    2020  Volume 60, Issue 8, Page(s) 976–977

    Keywords Pharmacology (medical) ; Pharmacology ; covid19
    Language English
    Publisher Wiley
    Publishing country us
    Document type Article ; Online
    ZDB-ID 188980-1
    ISSN 1552-4604 ; 0091-2700 ; 0021-9754
    ISSN (online) 1552-4604
    ISSN 0091-2700 ; 0021-9754
    DOI 10.1002/jcph.1669
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  7. Article ; Online: Comparative analysis of PD-1 target engagement of dostarlimab and pembrolizumab in advanced solid tumors using ex vivo IL-2 stimulation data.

    Austin, Daren / Melhem, Murad / Gandhi, Yash / Lu, Sharon / Visser, Sandra

    CPT: pharmacometrics & systems pharmacology

    2022  Volume 12, Issue 1, Page(s) 87–94

    Abstract: Dostarlimab (JEMPERLI) is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody (mAb) which is approved by the US Food and Drug Administration for patients with recurrent/advanced mismatch repair-deficient solid tumors, including endometrial ...

    Abstract Dostarlimab (JEMPERLI) is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody (mAb) which is approved by the US Food and Drug Administration for patients with recurrent/advanced mismatch repair-deficient solid tumors, including endometrial cancer, following progression on prior treatment, with approval based on data from the phase I GARNET trial. To support dostarlimab dose regimen recommendations, we estimated and compared the potency of dostarlimab relative to anti-PD-1 mAb pembrolizumab using both data published from the KEYNOTE-001 trial of pembrolizumab and data from the GARNET trial. PD-1 target engagement was assessed ex vivo in blood samples via a super antigen staphylococcal enterotoxin B stimulation assay and interleukin-2 (IL-2) stimulation ratios calculated for dostarlimab. A non-linear mixed-effect sigmoid maximum effect inhibitory model was fitted to dostarlimab IL-2 stimulation ratios using extracted pembrolizumab data as informative priors. The estimated half-maximal effective concentration was 1.95 μg ml
    MeSH term(s) Humans ; Interleukin-2/therapeutic use ; Antineoplastic Agents, Immunological ; Neoplasms/drug therapy ; Neoplasms/pathology
    Chemical Substances pembrolizumab (DPT0O3T46P) ; dostarlimab ; Interleukin-2 ; Antineoplastic Agents, Immunological
    Language English
    Publishing date 2022-11-16
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2697010-7
    ISSN 2163-8306 ; 2163-8306
    ISSN (online) 2163-8306
    ISSN 2163-8306
    DOI 10.1002/psp4.12878
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  8. Article ; Online: Justification of the Subcutaneous Mepolizumab Dose of 300 mg in Eosinophilic Granulomatosis With Polyangiitis and Hypereosinophilic Syndrome.

    Pouliquen, Isabelle J / Austin, Daren / Steinfeld, Jonathan / Yancey, Steven W

    Clinical therapeutics

    2021  Volume 43, Issue 7, Page(s) 1278–1280

    MeSH term(s) Antibodies, Monoclonal, Humanized ; Churg-Strauss Syndrome/diagnosis ; Churg-Strauss Syndrome/drug therapy ; Eosinophils ; Granulomatosis with Polyangiitis/diagnosis ; Granulomatosis with Polyangiitis/drug therapy ; Humans ; Hypereosinophilic Syndrome/diagnosis ; Hypereosinophilic Syndrome/drug therapy
    Chemical Substances Antibodies, Monoclonal, Humanized ; mepolizumab (90Z2UF0E52)
    Language English
    Publishing date 2021-06-27
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 603113-4
    ISSN 1879-114X ; 0149-2918
    ISSN (online) 1879-114X
    ISSN 0149-2918
    DOI 10.1016/j.clinthera.2021.05.014
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  9. Article ; Online: Hydroxychloroquine and azithromycin as potential treatments for COVID-19; clinical status impacts the outcome.

    Okour, Malek / Al-Kofahi, Mahmoud / Austin, Daren

    Journal of pharmacokinetics and pharmacodynamics

    2020  Volume 47, Issue 3, Page(s) 187–188

    MeSH term(s) Azithromycin/therapeutic use ; Betacoronavirus/drug effects ; COVID-19 ; Clinical Trials as Topic ; Coronavirus Infections/diagnosis ; Coronavirus Infections/drug therapy ; Coronavirus Infections/physiopathology ; Coronavirus Infections/virology ; Drug Therapy, Combination ; Humans ; Hydroxychloroquine/blood ; Hydroxychloroquine/pharmacokinetics ; Hydroxychloroquine/therapeutic use ; Models, Biological ; Pandemics ; Pneumonia, Viral/diagnosis ; Pneumonia, Viral/drug therapy ; Pneumonia, Viral/physiopathology ; Pneumonia, Viral/virology ; SARS-CoV-2 ; Treatment Outcome ; Viral Load/drug effects
    Chemical Substances Hydroxychloroquine (4QWG6N8QKH) ; Azithromycin (83905-01-5)
    Keywords covid19
    Language English
    Publishing date 2020-05-13
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2041601-5
    ISSN 1573-8744 ; 1567-567X
    ISSN (online) 1573-8744
    ISSN 1567-567X
    DOI 10.1007/s10928-020-09689-x
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  10. Article ; Online: Fetal brain growth and infant autistic traits.

    Aydin, Ezra / Tsompanidis, Alex / Chaplin, Daren / Hawkes, Rebecca / Allison, Carrie / Hackett, Gerald / Austin, Topun / Padaigaitė, Eglė / Gabis, Lidia V / Sucking, John / Holt, Rosemary / Baron-Cohen, Simon

    Molecular autism

    2024  Volume 15, Issue 1, Page(s) 11

    Abstract: Background: Structural differences exist in the brains of autistic individuals. To date only a few studies have explored the relationship between fetal brain growth and later infant autistic traits, and some have used fetal head circumference (HC) as a ... ...

    Abstract Background: Structural differences exist in the brains of autistic individuals. To date only a few studies have explored the relationship between fetal brain growth and later infant autistic traits, and some have used fetal head circumference (HC) as a proxy for brain development. These findings have been inconsistent. Here we investigate whether fetal subregional brain measurements correlate with autistic traits in toddlers.
    Methods: A total of 219 singleton pregnancies (104 males and 115 females) were recruited at the Rosie Hospital, Cambridge, UK. 2D ultrasound was performed at 12-, 20- and between 26 and 30 weeks of pregnancy, measuring head circumference (HC), ventricular atrium (VA) and transcerebellar diameter (TCD). A total of 179 infants were followed up at 18-20 months of age and completed the quantitative checklist for autism in toddlers (Q-CHAT) to measure autistic traits.
    Results: Q-CHAT scores at 18-20 months of age were positively associated with TCD size at 20 weeks and with HC at 28 weeks, in univariate analyses, and in multiple regression models which controlled for sex, maternal age and birth weight.
    Limitations: Due to the nature and location of the study, ascertainment bias could also have contributed to the recruitment of volunteer mothers with a higher than typical range of autistic traits and/or with a significant interest in the neurodevelopment of their children.
    Conclusion: Prenatal brain growth is associated with toddler autistic traits and this can be ascertained via ultrasound starting at 20 weeks gestation.
    MeSH term(s) Male ; Infant ; Pregnancy ; Female ; Humans ; Autistic Disorder/diagnostic imaging ; Brain/diagnostic imaging ; Gestational Age
    Language English
    Publishing date 2024-02-28
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2540930-X
    ISSN 2040-2392 ; 2040-2392
    ISSN (online) 2040-2392
    ISSN 2040-2392
    DOI 10.1186/s13229-024-00586-5
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