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Article ; Online: Artificial Intelligence and Machine Learning: Will Clinical Pharmacologists Be Needed in the Next Decade? The John Henry Question.

Corrigan, Brian W

2020 Volume 107, Issue 4, Page(s) 697–699

MeSH term(s)	Artificial Intelligence ; Humans ; Machine Learning ; Pharmacology, Clinical/methods ; Professional Role
Language	English
Publishing date	2020-02-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.1792
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Article ; Online: Role of Disease Progression Models in Drug Development.

Barrett, Jeffrey S / Nicholas, Tim / Azer, Karim / Corrigan, Brian W

Pharmaceutical research

2022 Volume 39, Issue 8, Page(s) 1803–1815

Abstract: The use of Disease progression models (DPMs) in Drug Development has been widely adopted across therapeutic areas as a method for integrating previously obtained disease knowledge to elucidate the impact of novel therapeutics or vaccines on disease ... ...

Abstract	The use of Disease progression models (DPMs) in Drug Development has been widely adopted across therapeutic areas as a method for integrating previously obtained disease knowledge to elucidate the impact of novel therapeutics or vaccines on disease course, thus quantifying the potential clinical benefit at different stages of drug development programs. This paper provides a brief overview of DPMs and the evolution in data types, analytic methods, and applications that have occurred in their use by Quantitive Clinical Pharmacologists. It also provides examples of how these models have informed decisions and clinical trial design across several therapeutic areas and at various stages of development. It briefly describes potential new applications of DPMs utilizing emerging data sources, and utilizing new analytic techniques, and discuss new challenges faced such as requiring description of multiple endpoints, rapid model development, application of machine learning-based analytics, and use of high dimensional and real-world data. Considerations for the continued evolution future of DPMs to serve as community-maintained expert systems are also provided.
MeSH term(s)	Clinical Trials as Topic ; Disease Progression ; Drug Development ; Humans ; Research Design
Language	English
Publishing date	2022-04-11
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	843063-9
ISSN	1573-904X ; 0724-8741 ; 0739-0742
ISSN (online)	1573-904X
ISSN	0724-8741 ; 0739-0742
DOI	10.1007/s11095-022-03257-3
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Article ; Online: Fishery catch records support machine learning-based prediction of illegal fishing off US West Coast.

Watson, Jordan T / Ames, Robert / Holycross, Brett / Suter, Jenny / Somers, Kayleigh / Kohler, Camille / Corrigan, Brian

PeerJ

2023 Volume 11, Page(s) e16215

Abstract: Illegal, unreported, and unregulated (IUU) fishing is a major problem worldwide, often made more challenging by a lack of at-sea and shoreside monitoring of commercial fishery catches. Off the US West Coast, as in many places, a primary concern for ... ...

Abstract	Illegal, unreported, and unregulated (IUU) fishing is a major problem worldwide, often made more challenging by a lack of at-sea and shoreside monitoring of commercial fishery catches. Off the US West Coast, as in many places, a primary concern for enforcement and management is whether vessels are illegally fishing in locations where they are not permitted to fish. We explored the use of supervised machine learning analysis in a partially observed fishery to identify potentially illicit behaviors when vessels did not have observers on board. We built classification models (random forest and gradient boosting ensemble tree estimators) using labeled data from nearly 10,000 fishing trips for which we had landing records (
MeSH term(s)	Animals ; Humans ; Conservation of Natural Resources ; Fisheries ; Hunting ; Research Personnel ; Machine Learning
Language	English
Publishing date	2023-10-19
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2703241-3
ISSN	2167-8359 ; 2167-8359
ISSN (online)	2167-8359
ISSN	2167-8359
DOI	10.7717/peerj.16215
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Article ; Online: Clinical Pharmacology Perspectives on the Antiviral Activity of Azithromycin and Use in COVID-19.

Damle, Bharat / Vourvahis, Manoli / Wang, Erjian / Leaney, Joanne / Corrigan, Brian

Clinical pharmacology and therapeutics

2020 Volume 108, Issue 2, Page(s) 201–211

Abstract: Azithromycin (AZ) is a broad-spectrum macrolide antibiotic with a long half-life and a large volume of distribution. It is primarily used for the treatment of respiratory, enteric, and genitourinary bacterial infections. AZ is not approved for the ... ...

Abstract	Azithromycin (AZ) is a broad-spectrum macrolide antibiotic with a long half-life and a large volume of distribution. It is primarily used for the treatment of respiratory, enteric, and genitourinary bacterial infections. AZ is not approved for the treatment of viral infections, and there is no well-controlled, prospective, randomized clinical evidence to support AZ therapy in coronavirus disease 2019 (COVID-19). Nevertheless, there are anecdotal reports that some hospitals have begun to include AZ in combination with hydroxychloroquine or chloroquine (CQ) for treatment of COVID-19. It is essential that the clinical pharmacology (CP) characteristics of AZ be considered in planning and conducting clinical trials of AZ alone or in combination with other agents, to ensure safe study conduct and to increase the probability of achieving definitive answers regarding efficacy of AZ in the treatment of COVID-19. The safety profile of AZ used as an antibacterial agent is well established.
MeSH term(s)	Antiviral Agents/pharmacology ; Antiviral Agents/therapeutic use ; Azithromycin/adverse effects ; Azithromycin/pharmacokinetics ; Azithromycin/pharmacology ; Azithromycin/therapeutic use ; Betacoronavirus/drug effects ; Betacoronavirus/pathogenicity ; Clinical Trials as Topic ; Coronavirus Infections/drug therapy ; Drug Therapy, Combination ; Humans ; Hydroxychloroquine/pharmacology ; Lung/drug effects ; Microbial Sensitivity Tests
Chemical Substances	Antiviral Agents ; Hydroxychloroquine (4QWG6N8QKH) ; Azithromycin (83905-01-5)
Keywords	covid19
Language	English
Publishing date	2020-05-12
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.1857
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Article ; Online: Ensuring diversity in clinical trials: The role of clinical pharmacology.

Masters, Joanna C / Cook, Jack A / Anderson, Ginger / Nucci, Gianluca / Colzi, Anna / Hellio, Marie-Pierre / Corrigan, Brian

Contemporary clinical trials

2022 Volume 118, Page(s) 106807

Abstract: Increasing the diversity of participants in clinical trials is important as it allows further examination of drug effects in all subgroups of patients who will be prescribed an approved medicine. It also gives patients more confidence in the medicine ... ...

Abstract	Increasing the diversity of participants in clinical trials is important as it allows further examination of drug effects in all subgroups of patients who will be prescribed an approved medicine. It also gives patients more confidence in the medicine when they know that individuals similar to themselves have participated in pivotal efficacy and safety trials. Pfizer recently committed to ensuring that its clinical trials reflect racial and ethnic demographics of the patient populations in the countries and communities in which the trials are conducted. This paper furthers Pfizer's commitment by declaring what Clinical Pharmacology (CP) can do to advance this goal and expand patient populations to include other groups such as pediatrics, elderly, and those with organ impairment. This includes steps such as: Pfizer Clinical Pharmacology commits to these actions, which create a framework for the CP Community to enable increased diversity among participants in clinical trials and improved dosing recommendations for all patient subgroups.
MeSH term(s)	Aged ; Child ; Clinical Trials as Topic ; Cultural Diversity ; Ethnicity ; Humans ; Pharmacology, Clinical ; Racial Groups
Language	English
Publishing date	2022-05-27
Publishing country	United States
Document type	Journal Article
ZDB-ID	2182176-8
ISSN	1559-2030 ; 1551-7144
ISSN (online)	1559-2030
ISSN	1551-7144
DOI	10.1016/j.cct.2022.106807
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Article ; Online: Preservation and Storage Mechanisms for Raw Milk Samples for Use in Milk-Recording Schemes.

Monardes, Humberto G / Moore, Robert K / Corrigan, Brian / Rioux, Yvon

Journal of food protection

2019 Volume 59, Issue 2, Page(s) 151–154

Abstract: This study, carried out by the Quebec Dairy Herd Analysis Service, compares (during summer conditions in Quebec) the performance of three types of preservatives for raw milk under four different systems of sample storage: no refrigeration, refrigeration ... ...

Abstract	This study, carried out by the Quebec Dairy Herd Analysis Service, compares (during summer conditions in Quebec) the performance of three types of preservatives for raw milk under four different systems of sample storage: no refrigeration, refrigeration at the laboratory only, refrigeration during transport and at the lab, and complete refrigeration from sampling at the farm to analysis. The objective was to determine the best preservative and storage conditions for protecting milk components during transportation and storage of raw milk samples collected at the farm and sent to a central testing lab for analysis. Milk samples were analyzed at day 3 and at day 7 after sampling to observe the effect of aging. A total of 12,480 samples were collected during the trial. The components studied were percentage of fat and protein and somatic cell count (SCC). In general, samples preserved with bronopol (2-bromo-2-nitropropane-1,3-diol and 2-bromo-2-nitropropanol) in liquid or in microtab tended to give higher readings for fat and protein contents than samples preserved with potassium dichromate. Significantly lower fat values were observed in 7-day-old samples compared to 3-day-old samples. Fat depression was more accentuated in nonrefrigerated samples. Under current methods of handling raw milk samples, refrigeration during the whole process of sampling, transportation, and until analysis, seems an ideal to attain to avoid significant reductions of fat values.
Language	English
Publishing date	2019-06-18
Publishing country	United States
Document type	Journal Article
ZDB-ID	243284-5
ISSN	1944-9097 ; 0362-028X
ISSN (online)	1944-9097
ISSN	0362-028X
DOI	10.4315/0362-028X-59.2.151
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Article ; Online: Patient Centric Microsampling to Support Paxlovid Clinical Development: Bridging and Implementation.

Wan, Katty / Kavetska, Olga / Damle, Bharat / Shi, Haihong / Cox, Donna S / Oladoyinbo, Olayide / Chan, Phylinda / Singh, Ravi Shankar P / Craft, Susan / Berthier, Erwin / Corrigan, Brian

Clinical pharmacology and therapeutics

2023 Volume 115, Issue 1, Page(s) 42–51

Abstract: Nirmatrelvir is a potent and selective severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) main protease inhibitor. Nirmatrelvir co-packaged with ritonavir (as PAXLOVID) received US Food and Drug Administration (FDA) Emergency Use Authorization ( ...

Abstract	Nirmatrelvir is a potent and selective severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) main protease inhibitor. Nirmatrelvir co-packaged with ritonavir (as PAXLOVID) received US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) on December 22, 2021, as an oral treatment for coronavirus disease 2019 (COVID-19) and subsequent new drug application approval on May 25, 2023. Pharmacokinetic (PK) capillary blood sampling at-home using Tasso-M20 micro-volumetric sampling device was implemented in the program, including three phase II/III outpatient and several clinical pharmacology studies supporting the EUA. The at-home sampling complemented venous blood sampling procedures to enrich the PK dataset, to decrease the need for patients' site visit for PK sampling, and to allow different sampling approaches for flexibility and convenience. To demonstrate concordance/equivalence, bridging between venous plasma and Tasso dried blood results was conducted by comparing concentrations and derived PK parameters from both sampling approaches. In addition, a two-compartment population PK model was utilized to bridge the plasma and Tasso data by estimating the PK parameters using blood-to-plasma ratio as a slope parameter. Operational challenges were successfully managed to implement at-home PK sampling in global phase II/III trials. Sample quality was generally very good with less than 3% samples deemed as "not usable" from over 800 samples collected in all the studies. Experience gained from sites and patients will guide future broader implementations.
MeSH term(s)	United States ; Humans ; Lactams ; Leucine ; Ritonavir ; Patient-Centered Care
Chemical Substances	nirmatrelvir and ritonavir drug combination ; Lactams ; Leucine (GMW67QNF9C) ; Ritonavir (O3J8G9O825)
Language	English
Publishing date	2023-09-05
Publishing country	United States
Document type	Journal Article
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.3025
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Book: Vertebral musculosketal disorders

Corrigan, Brian / Maitland, G. D.

1998

Author's details	Brian Corrigan ; G. D. Maitland
Language	English
Size	VII, 259 S. : zahlr. Ill.
Publisher	Butterworth-Heinemann
Publishing place	Oxford u.a.
Publishing country	Great Britain
Document type	Book
HBZ-ID	HT009216819
ISBN	0-7506-2965-7 ; 978-0-7506-2965-2
Database	Catalogue ZB MED Medicine, Health

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Shelf mark	Loan status	Location
1998 A 7370	order for loan	Magazin

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Article ; Online ; Conference proceedings: The American Conference on Pharmacometrics 2016 (ACoP7).

Ouellet, Daniele / Trame, Mirjam N / Corrigan, Brian

Journal of pharmacokinetics and pharmacodynamics

2016 Volume 43, Issue Suppl 1, Page(s) 1–2

MeSH term(s)	Pharmacology ; United States
Language	English
Publishing date	2016-10-03
Publishing country	United States
Document type	Congresses
ZDB-ID	2041601-5
ISSN	1573-8744 ; 1567-567X
ISSN (online)	1573-8744
ISSN	1567-567X
DOI	10.1007/s10928-016-9488-7
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Article: Clinical Pharmacology Perspectives on the Antiviral Activity of Azithromycin and Use in COVID-19

Damle, Bharat / Vourvahis, Manoli / Wang, Erjian / Leaney, Joanne / Corrigan, Brian

Clin Pharmacol Ther

Abstract	Azithromycin (AZ) is a broad-spectrum macrolide antibiotic with a long half-life and a large volume of distribution. It is primarily used for the treatment of respiratory, enteric, and genitourinary bacterial infections. AZ is not approved for the treatment of viral infections, and there is no well-controlled, prospective, randomized clinical evidence to support AZ therapy in coronavirus disease 2019 (COVID-19). Nevertheless, there are anecdotal reports that some hospitals have begun to include AZ in combination with hydroxychloroquine or chloroquine (CQ) for treatment of COVID-19. It is essential that the clinical pharmacology (CP) characteristics of AZ be considered in planning and conducting clinical trials of AZ alone or in combination with other agents, to ensure safe study conduct and to increase the probability of achieving definitive answers regarding efficacy of AZ in the treatment of COVID-19. The safety profile of AZ used as an antibacterial agent is well established.1 This work assesses published in vitro and clinical evidence for AZ as an agent with antiviral properties. It also provides basic CP information relevant for planning and initiating COVID-19 clinical studies with AZ, summarizes safety data from healthy volunteer studies, and safety and efficacy data from phase II and phase II/III studies in patients with uncomplicated malaria, including a phase II/III study in pediatric patients following administration of AZ and CQ in combination. This paper may also serve to facilitate the consideration and use of a priori-defined control groups for future research.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #72333
Database	COVID19

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