Preparing for Subsequent Entry Biologies in Dermatology and Rheumatology in Canada

2013 ◽  
Vol 17 (5) ◽  
pp. 340-346 ◽  
Author(s):  
Kim Papp ◽  
Marc Bourcier ◽  
Vincent Ho ◽  
Karen Burke ◽  
Boulos Haraoui
Keyword(s):  
Clinical Practice ◽  
Clinical Development ◽  
Draft Guidance ◽  
Therapeutic Equivalence ◽  
Development Programs ◽  
Regulatory Pathway ◽  
Key Issues ◽  
Therapeutic Interchange ◽  
Health Canada ◽  
Case Basis

Background: Patents on several biologies will expire in Canada in the coming years. As they expire, applications to market subsequent entry biologies (SEBs) may be filed in Canada. Objective: To provide an understanding of the regulatory pathway and types of trials used for SEB authorization in Canada. Methods: Health Canada's draft guidance on SEBs was reviewed in regards to key issues and challenges in the development and authorization of SEBs. Results: Health Canada states that SEBs are not “generic biologies” and their authorization is not a declaration of pharmaceutical or therapeutic equivalence to the originator. The agency recommends that physicians make well-informed decisions regarding therapeutic interchange. Conclusions: Decisions on how to determine the place of SEBs in clinical practice for biologic-naive patients and those already receiving biologies should be made on a case-by-case basis, considering the patient's needs, the characteristics of the biologic required, and the clinical development programs of the applicable SEB.

scholarly journals Biomarkers of Angiogenesis and Neuroplasticity as Promising Clinical Tools for Stroke Recovery Evaluation

2021 ◽  
Vol 22 (8) ◽  
pp. 3949
Author(s):  
Lidia Wlodarczyk ◽  
Rafal Szelenberger ◽  
Natalia Cichon ◽  
Joanna Saluk-Bijak ◽  
Michal Bijak ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Stroke Recovery ◽  
Clinical Scales ◽  
Recovery Processes ◽  
Recovery Potential ◽  
Current State ◽  
Standard Procedures ◽  
Key Issues ◽  
Clinical Tools ◽  
Selection Of

Several key issues impact the clinical practice of stroke rehabilitation including a patient’s medical history, stroke experience, the potential for recovery, and the selection of the most effective type of therapy. Until clinicians have answers to these concerns, the treatment and rehabilitation are rather intuitive, with standard procedures carried out based on subjective estimations using clinical scales. Therefore, there is a need to find biomarkers that could predict brain recovery potential in stroke patients. This review aims to present the current state-of-the-art stroke recovery biomarkers that could be used in clinical practice. The revision of biochemical biomarkers has been developed based on stroke recovery processes: angiogenesis and neuroplasticity. This paper provides an overview of the biomarkers that are considered to be ready-to-use in clinical practice and others, considered as future tools. Furthermore, this review shows the utility of biomarkers in the development of the concept of personalized medicine. Enhancing brain neuroplasticity and rehabilitation facilitation are crucial concerns not only after stroke, but in all central nervous system diseases.

Regulatory and Technical Challenges in Incorporating Surrogate Tissue Profiling Strategies into Clinical Development Programs

2005 ◽  
pp. 249-261
Author(s):  
William Trepicchio ◽  
Monica Cahilly ◽  
Lisa Speicher ◽  
Judith Oestreicher ◽  
Michael Burczynski ◽  
...  
Keyword(s):  
Clinical Development ◽  
Development Programs ◽  
Tissue Profiling ◽  
Surrogate Tissue ◽  
Technical Challenges

L'analisi del DNA mediante citometria a flusso nei tumori superficiali della vescica: DNA analysis through flow cytometry in superficial bladder tumours

1995 ◽  
Vol 62 (2) ◽  
pp. 188-195
Author(s):  
R. Pianon ◽  
A. D'Amico ◽  
M. Rahmati ◽  
A. Paganelli ◽  
D. Schiavone ◽  
...  
Keyword(s):  
Flow Cytometry ◽  
Clinical Practice ◽  
Dna Analysis ◽  
Prognostic Significance ◽  
Clinical Development ◽  
Dna Flow Cytometry ◽  
Through Flow ◽  
Data Investigation ◽  
Precise Role ◽  
Bladder Tumours

The aim of this work is to try to characterize the prognostic value of DNA flow cytometry in superficial bladder tumours and to try to indicate this investigation in clinical practice. The Authors review results reported in literature and those relative to their experience. Data investigation shows that this test has prognostic significance because it is correlated with the stage and grade of the tumour. The correlation with the clinical development of the tumour is not clear in the Authors’ experience. The Authors think that flow cytometry does not have a precise role in clinical practice.

scholarly journals Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs

Drug Safety ◽  
2019 ◽  
Vol 42 (6) ◽  
pp. 751-768 ◽  
Author(s):  
Subrata Ghosh ◽  
Lianne S. Gensler ◽  
Zijiang Yang ◽  
Chris Gasink ◽  
Soumya D. Chakravarty ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Psoriatic Arthritis ◽  
Crohn's Disease ◽  
Phase Ii ◽  
Clinical Development ◽  
Integrated Analysis ◽  
Development Programs

The Quest for New Anticoagulants: From Clinical Development to Clinical Practice

2010 ◽  
Vol 29 (6) ◽  
pp. e12-e22 ◽  
Author(s):  
Stavros Apostolakis ◽  
Gregory YH Lip ◽  
Deirdre A Lane ◽  
Eduard Shantsila
Keyword(s):  
Clinical Practice ◽  
Clinical Development ◽  
New Anticoagulants

Raising Orphans: How Clinical Development Programs of Drugs for Rare and Common Diseases Are Different

2012 ◽  
Vol 92 (2) ◽  
pp. 262-264 ◽  
Author(s):  
M Orfali ◽  
L Feldman ◽  
V Bhattacharjee ◽  
P Harkins ◽  
S Kadam ◽  
...  
Keyword(s):  
Clinical Development ◽  
Development Programs ◽  
Common Diseases

scholarly journals Publishing with impact factor – a blessing or a curse?

2015 ◽  
Vol 9 (1) ◽  
pp. 28-31
Author(s):  
Christos Lionis
Keyword(s):  
Clinical Practice ◽  
Impact Factor ◽  
Research Capacity ◽  
Publishing Research ◽  
Associate Editor ◽  
Biomedical Journals ◽  
Personal Experiences ◽  
Research Findings ◽  
Key Issues

Reporting and publishing research from a country with limited research capacity experiences from an editor Christos Lionis as chief and associate editor that serves certain European and International biomedical journals presents key issues that researchers need to be aware when they prepare, present and submit their work to maximise their chances of publication. Sufficient reporting and all the steps: (a) Planning ahead or thinking about the type or research, (b) Choosing a suitable journal, (c) Considering what before submission – are discussed in the article. However, a successful publication with an impact factor in a well-recognized journal is not only achieved by the fundamental steps that the author needs to undertake but also by certain “secrets” which are presented within the paper. Common pitfalls when research is reported will be highlighted by the author, while recommendations for a successful reporting of the research findings. To what extent publishing with impact factor is a blessing or a curse would be also approached within the paper. The information that this article provides is based on personal experiences of an editor in certain biomedical journals but it is important not to forget that in clinical practice it is critical to be passionate about discoveries to make an effect in regards to the patients’ benefits.

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