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Article ; Online: When Learn/Confirm Leads to Expand/Understand: The Expanding Role of Quantitative Systems Pharmacology in the Betterment of Therapeutics Development.

Riggs, Matthew M

2018 Volume 105, Issue 3, Page(s) 558–560

MeSH term(s)	Drug Delivery Systems ; Drug Discovery ; Humans ; Hypoparathyroidism ; Parathyroid Hormone
Chemical Substances	Parathyroid Hormone
Language	English
Publishing date	2018-12-18
Publishing country	United States
Document type	Journal Article ; Comment
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.1287
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Article ; Online: Pharmacometrics and systems pharmacology for metabolic bone diseases.

Riggs, Matthew M / Cremers, Serge

British journal of clinical pharmacology

2019 Volume 85, Issue 6, Page(s) 1136–1146

Abstract: Mathematical modelling and simulation (M&S) of drug concentrations, pharmacologic effects and the (patho)physiologic systems within which they interact can be powerful tools for the preclinical, translational and clinical development of drugs. Indeed, ... ...

Abstract	Mathematical modelling and simulation (M&S) of drug concentrations, pharmacologic effects and the (patho)physiologic systems within which they interact can be powerful tools for the preclinical, translational and clinical development of drugs. Indeed, the Prescription Drug User Fee Act (PDUFA VI), incorporated as part of the FDA Reauthorization Act of 2017 (FDARA), highlights the goal of advancing model-informed drug development (MIDD). MIDD can benefit development across many drug classes, including for metabolic bone diseases such as osteoporosis, cancer-related and numerous rare metabolic bone diseases; conditions characterized by significant morbidity and mortality. A drought looms in terms of the availability of new drugs to better treat these devastating diseases. This review provides an overview of several M&S approaches ranging from simple pharmacokinetic to integrated pharmacometric and systems pharmacology modelling. Examples are included to illustrate the use of these approaches during the development of several drugs for metabolic bone diseases such as bisphosphonates, denosumab, teriparatide and sclerostin inhibitors (romosozumab and blosozumab).
MeSH term(s)	Animals ; Bone Density Conservation Agents/adverse effects ; Bone Density Conservation Agents/pharmacokinetics ; Bone Density Conservation Agents/therapeutic use ; Bone Diseases, Metabolic/drug therapy ; Bone Diseases, Metabolic/physiopathology ; Bone Remodeling/drug effects ; Computer Simulation ; Drug Development/methods ; Drug Monitoring ; Humans ; Models, Biological ; Patient Safety ; Risk Assessment ; Systems Biology
Chemical Substances	Bone Density Conservation Agents
Language	English
Publishing date	2019-02-28
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.13881
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Article ; Online: A population pharmacokinetic-pharmacodynamic model evaluating efficacy of nalbuphine extended-release in patients with prurigo nodularis.

Eudy-Byrne, Rena / Riggs, Matthew / Hawi, Amale / Sciascia, Thomas / Rohatagi, Shashank

British journal of clinical pharmacology

2023 Volume 89, Issue 7, Page(s) 2088–2101

Abstract: Aims: Population pharmacokinetic (PK) and pharmacokinetic-pharmacodynamic (PK-PD) models were used to describe the exposure-response (E-R) relationship between nalbuphine exposure and two widely used rating scales for itch: the Numerical Rating Scale ... ...

Abstract	Aims: Population pharmacokinetic (PK) and pharmacokinetic-pharmacodynamic (PK-PD) models were used to describe the exposure-response (E-R) relationship between nalbuphine exposure and two widely used rating scales for itch: the Numerical Rating Scale for the subject's 'average'; itch experience (NRS-AV) and the Worst Itch (WI-NRS), with 24-h recall. Simulations based on the model E-R relationship were used to support dose selection for Phase 3 clinical trials and were evaluated with a target of reducing the 7-day average of the 24-h WI-NRS by at least 30% from baseline in most of the analysis population. Methods: Data from two clinical trials (NCT02373215: 9 healthy subjects; NCT02174419: 62 subjects with PN), in patients with prurigo nodularis (PN) with moderate to severe itch who received treatment with either of two doses of nalbuphine extended release (ER) or placebo, were used for the analysis. A two-compartment PK model with serial zero and first-order oral absorption was used to describe drug exposure. A maximum effect ( Results: The PK-PD model predicted the exposure-related reduction in both NRS-AV and WI-NRS over time with approximately 63% and 27% of Conclusion: Simulated dose response indicated that 108 and 162 mg BID doses result in the highest proportion of patients achieving at least a 30% reduction in NRS-AV and WI-NRS, respectively.
MeSH term(s)	Humans ; Prurigo/drug therapy ; Nalbuphine/adverse effects ; Pruritus/drug therapy
Chemical Substances	Nalbuphine (L2T84IQI2K)
Language	English
Publishing date	2023-02-09
Publishing country	England
Document type	Journal Article
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.15663
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Article: A Systematic Review of Large Agriculture Vehicles Use and Crash Incidents on Public Roads

Franklin, Richard. C / King, Jemma. C / Riggs, Matthew

Journal of agromedicine. 2020 Jan. 2, v. 25, no. 1

2020

Abstract: Background: Agricultural vehicles are a common sight on rural public roads. However, due to their larger mass (height, width, length, and weight), there are concerns about safety. The aim of this paper is to explore crash incidents on public roads of ... ...

Abstract	Background: Agricultural vehicles are a common sight on rural public roads. However, due to their larger mass (height, width, length, and weight), there are concerns about safety. The aim of this paper is to explore crash incidents on public roads of agricultural vehicles to determine the size of the problem, risk factors, and potential prevention strategies. Methods: A systematic review using the PRISMA guidelines was undertaken of peer-reviewed literature from Medline, Agricola, Scopus, PsycInfo, Science Direct, Web of Science, and SafetyLit. Crash incident rates, risk factors, and prevention strategies were extracted from the articles, and a review of quality was undertaken using McMasters guidelines. Results: Included in the review were 30 articles, with the majority from the United States. Crash risk rates, where reported, were low relative to agricultural vehicle use and when compared to overall road crash numbers. Crash risk factors included weather and visibility, age, personal and driving characteristics, road conditions, and event characteristics. Prevention strategies proposed were targeted at drivers and operators, vehicles, road design, driving behavior, and surveillance, policy, and technology. Conclusions: Overall, reported crash numbers involving large agricultural vehicles were low. Currently, there is limited capacity to calculate exposure rates compounded by the difficulties in identifying road incidents that involve agriculture vehicles. Better surveillance systems are required to improve our understanding of exposure and crash incident rates. Future research into the multiplicity of interrelated factors involved in agriculture vehicle crashes on roads, exposure rates, and evidence for the effectiveness of the prevention strategies is required.
Keywords	accidents ; guidelines ; issues and policy ; monitoring ; risk factors ; roads ; systematic review ; weather ; United States
Language	English
Dates of publication	2020-0102
Size	p. 14-27.
Publishing place	Taylor & Francis
Document type	Article
ZDB-ID	1289325-0
ISSN	1545-0813 ; 1059-924X
ISSN (online)	1545-0813
ISSN	1059-924X
DOI	10.1080/1059924X.2019.1593275
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: A model-based analysis to guide gonadotropin-releasing hormone receptor antagonist use for management of endometriosis.

Pohl, Oliver / Baron, Kyle / Riggs, Matthew / French, Jonathan / Garcia, Ramon / Gotteland, Jean-Pierre

British journal of clinical pharmacology

2022 Volume 88, Issue 5, Page(s) 2359–2371

Abstract: Aims: To identify linzagolix doses, an oral GnRH receptor antagonist, that effectively lower oestradiol (E2) to relieve endometriosis-related pelvic pain without compromising bone health.: Methods: Integrated statistical, pharmacokinetic- ... ...

Abstract	Aims: To identify linzagolix doses, an oral GnRH receptor antagonist, that effectively lower oestradiol (E2) to relieve endometriosis-related pelvic pain without compromising bone health. Methods: Integrated statistical, pharmacokinetic-pharmacodynamic and systems pharmacology models were developed from Phase 1 and 2 clinical trial data in healthy volunteers and patients, receiving linzagolix 25-200 mg daily or placebo, and analysed simultaneously. The main outcome measures were pelvic pain scores for dysmenorrhoea, nonmenstrual pelvic pain (NMPP), uterine bleeding and lumbar spine bone mineral density (BMD). Results: Linzagolix pharmacokinetics were described by a 2-compartment model with sequential zero/first-order absorption process (CL/F: 0.422 L/h). E2 changes over time were well described as a function of linzagolix 24-hour AUC (AUC Discussion: The previously-reported E2 target range (20-50 pg/mL) to balance efficacy and safety endpoints was confirmed. Linzagolix once daily doses between 75-125 mg daily were expected to meet endometriosis-associated pain, efficacy, and BMD loss targets in Caucasian patients.
MeSH term(s)	Bone Density ; Carboxylic Acids ; Dysmenorrhea/drug therapy ; Endometriosis/drug therapy ; Female ; Hormone Antagonists/pharmacology ; Hormone Antagonists/therapeutic use ; Humans ; Pelvic Pain/drug therapy ; Pyrimidines ; Receptors, LHRH/therapeutic use
Chemical Substances	Carboxylic Acids ; Hormone Antagonists ; Pyrimidines ; Receptors, LHRH ; linzagolix (7CDW97HUEX)
Language	English
Publishing date	2022-01-13
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.15171
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Article ; Online: Cardiopulmonary resuscitation (CPR) psychomotor skills of laypeople, as affected by training interventions, number of times trained and retention testing intervals: A dataset derived from a systematic review.

Riggs, Matthew / Franklin, Richard / Saylany, Lua

Data in brief

2019 Volume 25, Page(s) 104236

Abstract: This article is a companion to a systematic review, entitled, ...

Abstract	This article is a companion to a systematic review, entitled,
Language	English
Publishing date	2019-07-09
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2786545-9
ISSN	2352-3409 ; 2352-3409
ISSN (online)	2352-3409
ISSN	2352-3409
DOI	10.1016/j.dib.2019.104236
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Associations between cardiopulmonary resuscitation (CPR) knowledge, self-efficacy, training history and willingness to perform CPR and CPR psychomotor skills: A systematic review.

Riggs, Matthew / Franklin, Richard / Saylany, Lua

Resuscitation

2019 Volume 138, Page(s) 259–272

Abstract: Aim: To determine whether training history (including number of times and duration since last training), knowledge, self-efficacy or willingness are associated with cardiopulmonary resuscitation (CPR) psychomotor skills.: Methods: Eight databases ... ...

Abstract	Aim: To determine whether training history (including number of times and duration since last training), knowledge, self-efficacy or willingness are associated with cardiopulmonary resuscitation (CPR) psychomotor skills. Methods: Eight databases were systematically searched from January 2005 to February 2018 for articles that involved adult layperson participants and explored an association between training history, knowledge, self-efficacy or willingness and CPR psychomotor skills or survival outcomes after real CPR attempts. Results: Thirty-four articles with a total of 35,421 participants were included. CPR training was found to improve psychomotor skills, compared to no training, and any previous training was associated with better skills, compared to no previous training, however only the use of a popular song promoted meaningful retention of a specifically targeted skill, compared to standard training methods. Skills deteriorated within 3 months, then plateaued from 3 to 6 months. Self-efficacy was weakly associated with skill level, however knowledge was not associated with skill level. No studies assessed the association between willingness and psychomotor skills. Conclusion: All laypeople should attend an instructor-led CPR training session with real-time or delayed feedback to improve CPR skills. Training sessions should utilise combinations of validated skill-specific training strategies, preferably including popular songs and feedback to help ensure skills retention. Refresher training, which focusses on skills and self-confidence rather than knowledge, should be undertaken every 3-6 months, although this timeframe needs further validation. All future studies assessing CPR psychomotor skills should adhere to a standardised reporting outcome list (proposed in this paper) to ensure consistency and comparability of results.
MeSH term(s)	Cardiopulmonary Resuscitation/education ; Cardiopulmonary Resuscitation/methods ; Educational Measurement/methods ; Health Knowledge, Attitudes, Practice ; Heart Arrest/therapy ; Humans ; Manikins ; Psychomotor Performance/physiology ; Self Efficacy ; Students/psychology
Language	English
Publishing date	2019-03-27
Publishing country	Ireland
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Systematic Review
ZDB-ID	189901-6
ISSN	1873-1570 ; 0300-9572
ISSN (online)	1873-1570
ISSN	0300-9572
DOI	10.1016/j.resuscitation.2019.03.019
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Article ; Online: Quantitative Systems Pharmacology and Physiologically-Based Pharmacokinetic Modeling With mrgsolve: A Hands-On Tutorial.

Elmokadem, Ahmed / Riggs, Matthew M / Baron, Kyle T

CPT: pharmacometrics & systems pharmacology

2019 Volume 8, Issue 12, Page(s) 883–893

Abstract: mrgsolve is an open-source R package available on the Comprehensive R Archive Network. It combines R and C++ coding for simulation from hierarchical, ordinary differential equation-based models. Its efficient simulation engine and integration into a ... ...

Abstract	mrgsolve is an open-source R package available on the Comprehensive R Archive Network. It combines R and C++ coding for simulation from hierarchical, ordinary differential equation-based models. Its efficient simulation engine and integration into a parallelizable, R-based workflow makes mrgsolve a convenient tool both for simple and complex models and thus is ideal for physiologically-based pharmacokinetic (PBPK) and quantitative systems pharmacology (QSP) model. This tutorial will first introduce the basics of the mrgsolve simulation workflow, including model specification, the introduction of interventions (dosing events) into the simulation, and simulated results postprocessing. An applied simulation example is then presented using a PBPK model for voriconazole, including a model validation step against adult and pediatric data sets. A final simulation example is then presented using a previously published QSP model for mitogen-activated protein kinase signaling in colorectal cancer, illustrating population simulation of different combination therapies.
MeSH term(s)	Access to Information ; Computer Simulation ; Humans ; Models, Biological ; Pharmacology, Clinical/methods ; Software ; Systems Biology/methods
Language	English
Publishing date	2019-11-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	2697010-7
ISSN	2163-8306 ; 2163-8306
ISSN (online)	2163-8306
ISSN	2163-8306
DOI	10.1002/psp4.12467
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: A Systematic Review of Large Agriculture Vehicles Use and Crash Incidents on Public Roads.

Franklin, Richard C / King, Jemma C / Riggs, Matthew

Journal of agromedicine

2019 Volume 25, Issue 1, Page(s) 14–27

Abstract: ... ...

Abstract	Background
MeSH term(s)	Accidents, Occupational/prevention & control ; Accidents, Occupational/statistics & numerical data ; Accidents, Traffic/prevention & control ; Accidents, Traffic/statistics & numerical data ; Agriculture ; Automobile Driving/statistics & numerical data ; Humans ; Motor Vehicles/statistics & numerical data ; Risk Factors
Language	English
Publishing date	2019-03-30
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Systematic Review
ZDB-ID	1289325-0
ISSN	1545-0813 ; 1059-924X
ISSN (online)	1545-0813
ISSN	1059-924X
DOI	10.1080/1059924X.2019.1593275
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Article: Cardiopulmonary resuscitation (CPR) psychomotor skills of laypeople, as affected by training interventions, number of times trained and retention testing intervals: A dataset derived from a systematic review

Riggs, Matthew / Franklin, Richard / Saylany, Lua

Data in Brief. 2019 Aug., v. 25

2019

Abstract: This article is a companion to a systematic review, entitled, Associations between cardiopulmonary resuscitation (CPR) knowledge, self-efficacy, training history and willingness to perform CPR and CPR psychomotor skills: a systematic review (Riggs et al., ...

Abstract	This article is a companion to a systematic review, entitled, Associations between cardiopulmonary resuscitation (CPR) knowledge, self-efficacy, training history and willingness to perform CPR and CPR psychomotor skills: a systematic review (Riggs et al., 2019). The data tables described in this article summarise the impact that specific training interventions, number of times trained, and retention testing intervals have on laypeople's CPR psychomotor skills, as reported by peer-reviewed journal articles. The psychomotor skills included are: compression rate, compression depth, duration of interruptions to compressions, chest recoil, hand placement, proportion of adequate or ’correct’ compressions, ventilation volume, compression-to-ventilation ratio, duty cycle and overall skills. The data tables described in this article are available as a supplementary file to this article.
Keywords	cardiopulmonary resuscitation ; chest ; data collection ; self-efficacy ; systematic review
Language	English
Dates of publication	2019-08
Publishing place	Elsevier Inc.
Document type	Article
ZDB-ID	2786545-9
ISSN	2352-3409
ISSN	2352-3409
DOI	10.1016/j.dib.2019.104236
Database	NAL-Catalogue (AGRICOLA)

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