MARC details
000 -LEADER |
fixed length control field |
04374nam a22004695i 4500 |
001 - CONTROL NUMBER |
control field |
978-3-031-04402-1 |
003 - CONTROL NUMBER IDENTIFIER |
control field |
DE-He213 |
005 - DATE AND TIME OF LATEST TRANSACTION |
control field |
20240729134342.0 |
007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION |
fixed length control field |
cr nn 008mamaa |
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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221130s2022 sz | s |||| 0|eng d |
020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
ISBN |
9783031044021 |
-- |
978-3-031-04402-1 |
072 #7 - SUBJECT CATEGORY CODE |
Subject category code |
MJCL |
Source |
bicssc |
072 #7 - SUBJECT CATEGORY CODE |
Subject category code |
MED062000 |
Source |
bisacsh |
072 #7 - SUBJECT CATEGORY CODE |
Subject category code |
MJCL |
Source |
thema |
245 10 - TITLE STATEMENT |
Title |
Cancer Drug Safety and Public Health Policy |
Subtitle |
: A Changing Landscape / |
250 ## - EDITION |
Edition statement |
1st ed. 2022. |
264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE |
Place of production, publication, distribution, manufacture |
Cham : |
Name of producer, publisher, distributor, manufacturer |
Springer International Publishing : |
-- |
Imprint: Springer, |
Date of production, publication, distribution, manufacture, or copyright notice |
2022. |
300 ## - PHYSICAL DESCRIPTION |
Physical description |
XI, 167 p. 16 illus., 10 illus. in color. |
Other physical details |
online resource. |
336 ## - CONTENT TYPE |
Content type term |
text |
Content type code |
txt |
Source |
rdacontent |
337 ## - MEDIA TYPE |
Media type term |
computer |
Media type code |
c |
Source |
rdamedia |
338 ## - CARRIER TYPE |
Carrier type term |
online resource |
Carrier type code |
cr |
Source |
rdacarrier |
490 1# - SERIES TITLE |
Series statement |
Cancer Treatment and Research, |
International Standard Serial Number |
2509-8497 ; |
Volume |
184 |
505 0# - CONTENTS |
Contents |
Fluoroquinolone-Associated Disability and Other Fluoroquinolone Associated Serious Adverse Events: Unexpected Toxicities Have Emerged in Recent Years -- Biosimilar Epoetin in the United States: A View from the Southern Network on Adverse Reactions -- Policing of Drug Safety Information under the False Claims Act -- Translating Research Into Health Policy: The Citizen Petition Experience with the Food and Drug Administration -- Systemic Barriers and Potential Concerns from Reporting Serious Adverse Drug Reactions -- Was there Something Rotten in Denmark: Nephrogenic System Fibrosis Cases Occuring in Copenhagen -- Rituximab-associated Progressive Multifocal Leukoencephalopathy: A fatal adverse drug reaction -- Maximum Accuracy Machine Learning Statistical Analysis - A Novel Approach -- Investigating Severe Adverse Reactions: Examples of the ANTICIPATE Methodology at Work -- Consequences to patients, clinicians, and manufacturers when very serious adverse drug reactions are identified (1997-2019):A qualitative analysis from the Southern Network on Adverse Reactions (SONAR) -- Moderna, Pfizer-BioNTech, and Johnson & Johnson/Janssen Post-Covid Vaccine Hematological Adverse Events Including Cerebral Venous Sinus Thrombosis (CVST), Thrombotic Thrombocytopenia (VITT), Blood Clots, Increased Vaginal/Menstrual Bleeding and/or Miscarriage, Stillbirth Delivery, or Premature Birth -- Investigating Novel Genetic Fluoroquinolone Associated Disorders. |
520 ## - ABSTRACT |
Abstract |
This book offers a wide-ranging description and analysis of recent developments and current trends in health policy with regard to cancer drug safety. The book opens with an overview of pharmacovigilance for cancer blockbuster drugs, covering both general considerations and efforts to develop a structured framework for the identification and reporting of adverse drug reactions (ADRs). A number of important examples of serious ADRs to hematology and oncology drugs are then reviewed, with evaluation of the lessons learned and the policy implications of the ensuing legal cases and their settlements. Further, the difficulty of reporting such blockbuster side effects in the medical literature is explored in an empirical study. Significant advances have been achieved in analytic methods for the identification of ADRs, and here there is a particular focus on the value of optimal discriminant analysis. Finally, the impacts on pharmacovigilance and drug safety of the huge fines paid under the U.S. False Claims Act relating to the defrauding of governmental programs also receive careful attention - these fines are playing an important role in changing the landscape for pharmaceutical safety. |
650 #0 - SUBJECT HEADINGS |
Subject term |
Oncology. |
9 (RLIN) |
13364 |
650 #0 - SUBJECT HEADINGS |
Subject term |
Pharmacovigilance. |
650 14 - SUBJECT HEADINGS |
Subject term |
Oncology. |
9 (RLIN) |
13364 |
650 24 - SUBJECT HEADINGS |
Subject term |
Drug Safety and Pharmacovigilance. |
700 1# - ADDED PERSONAL NAME |
Added personal author |
Bennett, Charles. |
Relator term |
editor. |
700 1# - ADDED PERSONAL NAME |
Added personal author |
Lubaczewski, Courtney. |
Relator term |
editor. |
700 1# - ADDED PERSONAL NAME |
Added personal author |
Witherspoon, Bartlett. |
Relator term |
editor. |
710 2# - ADDED CORPORATE NAME |
Added corporate author |
SpringerLink (Online service) |
830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE |
Uniform title |
Cancer Treatment and Research, |
International Standard Serial Number |
2509-8497 ; |
Volume number/sequential designation |
184 |
856 ## - ONLINE RESOURCE |
Uniform Resource Identifier |
<a href="#gotoholdings">#gotoholdings</a> |
Link text |
Access resource |
245 ## - TITLE STATEMENT |
Medium |
[E-Book] |
347 ## - DIGITAL FILE CHARACTERISTICS |
File type |
text file |
Encoding format |
PDF |
Source |
rda |
912 ## - |
-- |
ZDB-2-SME |
912 ## - |
-- |
ZDB-2-SXM |