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PaperbackEngels9780367657765
30-9-2020
Praise for the Second Edition:
"… this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study. Meer
PaperbackEngels9780367377380
5-9-2019
A Western-Based Approach to Analyzing TCMs
In recent years, many pharmaceutical companies and clinical research organizations have been focusing on the development of traditional Chinese (herbal) medicines (TCMs) as alternatives to treating critical or life-threatening diseases and as pathways to personalized medicine. Meer
PaperbackEngels9780367577681
30-6-2020
The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Meer
PaperbackEngels9780367733834
18-12-2020
This book focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. Meer
GebondenEngels9780367502102
12-11-2020
Reviews critical issues (e.g., endpoint/margin selection, sample size requirement and complex innovative design). Provides better understanding of statistical concepts and methods which may be used in regulatory review and approval. Meer
PaperbackEngels9780367502904
30-5-2022
Reviews critical issues (e.g., endpoint/margin selection, sample size requirement and complex innovative design). Provides better understanding of statistical concepts and methods which may be used in regulatory review and approval. Meer
GebondenEngels9780367561789
26-5-2022
Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. Meer
PaperbackEngels9780367576936
30-6-2020
In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. Meer
PaperbackEngels9780367379728
23-10-2019
As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator’s biologic products. Meer
GebondenEngels9780367224769
7-11-2019
Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. Meer
PaperbackEngels9781032086538
30-6-2021
Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. Meer
GebondenEngels9781138307339
1-8-2018
This book focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. Meer
GebondenEngels9781138740983
30-8-2017
Praise for the Second Edition:
"… this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study. Meer
GebondenEngels9781439849613
15-6-2011
In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. Meer
GebondenEngels9781584889052
30-5-2007
The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Meer
paperbackEngels9781498733953
13-8-2018
Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. Meer
GebondenEngels9781466579699
29-7-2013
As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator’s biologic products. Meer
GebondenEngels9781482235999
6-10-2015
A Western-Based Approach to Analyzing TCMs
In recent years, many pharmaceutical companies and clinical research organizations have been focusing on the development of traditional Chinese (herbal) medicines (TCMs) as alternatives to treating critical or life-threatening diseases and as pathways to personalized medicine. Meer