Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines
https://libcat.nshealth.ca/en/permalink/provcat31841
by Tom Brody.
(2nd ed.)
--Amsterdam, Netherlands:
Elsevier
, c2016.
- Available Online
- View e-Book
- Access
- Registration required for PDF access.
- Location
- Online
Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous…
- Available Online
- View e-Book
- Author
- Brody, Tom
- Responsibility
- by Tom Brody
- Edition
- 2nd ed.
- Place of Publication
- Amsterdam, Netherlands
- Publisher
- Elsevier
- Date of Publication
- c2016
- Physical Description
- 1 online resource,
- ISBN
- 9780128042175
- Subjects (MeSH)
- Clinical Trials as Topic
- Clinical Trials Data Monitoring Committees
- Drug Approval
- Research Design
- Abstract
- Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials.
- Access
- Registration required for PDF access.
- Format
- e-Book
- Location
- Online
Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines
https://libcat.nshealth.ca/en/permalink/provcat50526
Brody, Tom.
(2nd ed.)
--Philadelphia, PA:
Elsevier
, 2016.
- Available Online
- View e-Book
- Location
- Online
- Available Online
- View e-Book
- Author
- Brody, Tom
- Edition
- 2nd ed.
- Place of Publication
- Philadelphia, PA
- Publisher
- Elsevier
- Date of Publication
- 2016
- ISBN
- 9780128042175
- Subjects (MeSH)
- Clinical Trials as Topic
- Clinical Trials Data Monitoring Committees
- Drug Approval
- Research Design
- Notes
- Access to this online resource is restricted to IWK Health Centre employees working from inside the hospital network.
- Format
- e-Book
- Location
- Online
The CRA's guide to monitoring clinical research
https://libcat.nshealth.ca/en/permalink/provcat22643
Woodin, Karen E.
--Boston, MA:
Thomson CenterWatch
, 2003.
- Call Number
- W 20.5 W891c 2003
- Location
- Halifax Infirmary
- Dickson Building
- Call Number
- W 20.5 W891c 2003
- Author
- Woodin, Karen E.
- Other Authors
- Schneider, John C.
- Place of Publication
- Boston, MA
- Publisher
- Thomson CenterWatch
- Date of Publication
- 2003
- Physical Description
- 448 p.
- ISBN
- 1930624379
- Subjects (MeSH)
- Clinical Trials as Topic - standards
- Clinical Trials Data Monitoring Committees
- Drug Approval - organization & administration
- Ethics, Research
- Guideline Adherence
- Research Design
- Research Support as Topic - organization & administration
- Format
- Book
- Location
- Halifax Infirmary
- Dickson Building
- Copies
- 2
- Loan Period
- 3 weeks
Data monitoring in clinical trials : a case studies approach
https://libcat.nshealth.ca/en/permalink/provcat22357
DeMets, David L.
--New York, NY:
Springer
, 2006.
- Call Number
- W 20.5 D232 2006
- Location
- Halifax Infirmary
- Call Number
- W 20.5 D232 2006
- Author
- DeMets, David L.
- Other Authors
- Furberg, Curt D.
- Friedman, Lawrence M.
- Place of Publication
- New York, NY
- Publisher
- Springer
- Date of Publication
- 2006
- Physical Description
- 374 p.
- ISBN
- 0387203303
- 9780387203300
- Subjects (MeSH)
- Biomedical Research - standards
- Clinical Trials Data Monitoring Committees
- Randomized Controlled Trials as Topic
- Format
- Book
- Location
- Halifax Infirmary
- Loan Period
- 3 weeks
Statistical monitoring of clinical trials : fundamentals for investigators
https://libcat.nshealth.ca/en/permalink/provcat22352
Moyé, Lemuel A.
--New York, NY:
Springer
, 2006.
- Call Number
- WA 950 M938s 2006
- Location
- Halifax Infirmary
- Call Number
- WA 950 M938s 2006
- Author
- Moyé, Lemuel A.
- Place of Publication
- New York, NY
- Publisher
- Springer
- Date of Publication
- 2006
- Physical Description
- 254 p.
- ISBN
- 0387277811
- 9780387277813
- Subjects (MeSH)
- Clinical Trials as Topic
- Statistics as Topic - methods
- Clinical Trials Data Monitoring Committees
- Format
- Book
- Location
- Halifax Infirmary
- Loan Period
- 3 weeks
