Statistics in regulatory science:
"The proposed book will focus on practical issues in pharmaceutical/clinical research and development from both regulatory and scientific perspectives. The book will outline and clarify those issues that have been commonly misused in the subject area of regulatory science"--
Gespeichert in:
1. Verfasser: | |
---|---|
Format: | Elektronisch E-Book |
Sprache: | English |
Veröffentlicht: |
Boca Raton
CRC Press
[2018]
|
Schriftenreihe: | CRC biostatistics series
|
Schlagworte: | |
Online-Zugang: | URL des Erstveröffentlichers |
Zusammenfassung: | "The proposed book will focus on practical issues in pharmaceutical/clinical research and development from both regulatory and scientific perspectives. The book will outline and clarify those issues that have been commonly misused in the subject area of regulatory science"-- |
Beschreibung: | Totality-of-the-evidence -- Hypotheses testing versus confidence interval -- Endpoint selection -- Non-inferiority margin -- Missing data -- Multiplicity -- Sample size -- Reproducible research -- Extrapolation -- Consistency evaluation -- Drug products with multiple components -- Adaptive trial design -- Selection criteria in adaptive dose finding -- Generic drugs and biosimilars -- Precision and personalized medicine -- Big data analytics -- Rare disease drug development |
Beschreibung: | 1 online resource |
ISBN: | 9780429275067 0429275064 9781000710816 1000710815 9781000710038 1000710033 |
DOI: | 10.4324/9780429275067 |
Internformat
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Datensatz im Suchindex
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author | Chow, Shein-Chung 1955- |
author_facet | Chow, Shein-Chung 1955- |
author_role | aut |
author_sort | Chow, Shein-Chung 1955- |
author_variant | s c c scc |
building | Verbundindex |
bvnumber | BV047052064 |
collection | ZDB-7-TFC |
ctrlnum | (ZDB-7-TFC)9780429275067 (OCoLC)1226704134 (DE-599)BVBBV047052064 |
dewey-full | 615.1072/4 |
dewey-hundreds | 600 - Technology (Applied sciences) |
dewey-ones | 615 - Pharmacology and therapeutics |
dewey-raw | 615.1072/4 |
dewey-search | 615.1072/4 |
dewey-sort | 3615.1072 14 |
dewey-tens | 610 - Medicine and health |
discipline | Medizin |
discipline_str_mv | Medizin |
doi_str_mv | 10.4324/9780429275067 |
format | Electronic eBook |
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id | DE-604.BV047052064 |
illustrated | Not Illustrated |
index_date | 2024-07-03T16:08:25Z |
indexdate | 2024-07-10T09:01:14Z |
institution | BVB |
isbn | 9780429275067 0429275064 9781000710816 1000710815 9781000710038 1000710033 |
language | English |
oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-032459405 |
oclc_num | 1226704134 |
open_access_boolean | |
physical | 1 online resource |
psigel | ZDB-7-TFC |
publishDate | 2018 |
publishDateSearch | 2018 |
publishDateSort | 2018 |
publisher | CRC Press |
record_format | marc |
series2 | CRC biostatistics series |
spelling | Chow, Shein-Chung 1955- aut Statistics in regulatory science by Shein-Chung Chow Boca Raton CRC Press [2018] 1 online resource txt rdacontent c rdamedia cr rdacarrier CRC biostatistics series Totality-of-the-evidence -- Hypotheses testing versus confidence interval -- Endpoint selection -- Non-inferiority margin -- Missing data -- Multiplicity -- Sample size -- Reproducible research -- Extrapolation -- Consistency evaluation -- Drug products with multiple components -- Adaptive trial design -- Selection criteria in adaptive dose finding -- Generic drugs and biosimilars -- Precision and personalized medicine -- Big data analytics -- Rare disease drug development "The proposed book will focus on practical issues in pharmaceutical/clinical research and development from both regulatory and scientific perspectives. The book will outline and clarify those issues that have been commonly misused in the subject area of regulatory science"-- MATHEMATICS / Probability & Statistics / General / bisacsh MEDICAL / Pharmacology / bisacsh REFERENCE / General / bisacsh Drugs Testing Clinical trials Statistical methods Pharmacy Research Research Statistical methods Erscheint auch als Druck-Ausgabe 9780367224769 https://doi.org/10.4324/9780429275067 Verlag URL des Erstveröffentlichers Volltext |
spellingShingle | Chow, Shein-Chung 1955- Statistics in regulatory science MATHEMATICS / Probability & Statistics / General / bisacsh MEDICAL / Pharmacology / bisacsh REFERENCE / General / bisacsh Drugs Testing Clinical trials Statistical methods Pharmacy Research Research Statistical methods |
title | Statistics in regulatory science |
title_auth | Statistics in regulatory science |
title_exact_search | Statistics in regulatory science |
title_exact_search_txtP | Statistics in regulatory science |
title_full | Statistics in regulatory science by Shein-Chung Chow |
title_fullStr | Statistics in regulatory science by Shein-Chung Chow |
title_full_unstemmed | Statistics in regulatory science by Shein-Chung Chow |
title_short | Statistics in regulatory science |
title_sort | statistics in regulatory science |
topic | MATHEMATICS / Probability & Statistics / General / bisacsh MEDICAL / Pharmacology / bisacsh REFERENCE / General / bisacsh Drugs Testing Clinical trials Statistical methods Pharmacy Research Research Statistical methods |
topic_facet | MATHEMATICS / Probability & Statistics / General / bisacsh MEDICAL / Pharmacology / bisacsh REFERENCE / General / bisacsh Drugs Testing Clinical trials Statistical methods Pharmacy Research Research Statistical methods |
url | https://doi.org/10.4324/9780429275067 |
work_keys_str_mv | AT chowsheinchung statisticsinregulatoryscience |