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FDA's drug review process and the package label : (Record no. 209323)

000 -LEADER
fixed length control field 03659cam a22004457i 4500
001 - CONTROL NUMBER
control field 20595394
003 - CONTROL NUMBER IDENTIFIER
control field OSt
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20220422112207.0
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 180723s2018 enkad b 001 0 eng d
010 ## - LIBRARY OF CONGRESS CONTROL NUMBER
LC control number 2017300270
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9780128146477 (pbk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 0128146478 (pbk.)
035 ## - SYSTEM CONTROL NUMBER
System control number (OCoLC)on1001456623
040 ## - CATALOGING SOURCE
Original cataloging agency BTCTA
Language of cataloging eng
Transcribing agency UNZA
Description conventions rda
Modifying agency YDX
-- BDX
-- TXQ
-- OCLCO
-- LBRTY
-- SLU
-- OCLCF
-- DLC
042 ## - AUTHENTICATION CODE
Authentication code lccopycat
050 00 - LIBRARY OF CONGRESS CALL NUMBER
Classification number R852.5
Item number BRO 2018
082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.1072/4
Edition number 23
100 1# - MAIN ENTRY--PERSONAL NAME
Personal name Brody, Tom,
Relator term author.
245 10 - TITLE STATEMENT
Title FDA's drug review process and the package label :
Remainder of title strategies for writing successful FDA submissions /
Statement of responsibility, etc. Tom Brody.
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Place of publication, distribution, etc. London, United Kingdom ;
-- San Diego, CA, United States :
Name of publisher, distributor, etc. Academic Press,
Date of publication, distribution, etc. c2018
264 #4 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE
Date of production, publication, distribution, manufacture, or copyright notice ©2018
300 ## - PHYSICAL DESCRIPTION
Extent xvi, 653 pages :
Other physical details illustrations, charts ;
Dimensions 24 cm
336 ## - CONTENT TYPE
Content type term text
Content type code txt
Source rdacontent
337 ## - MEDIA TYPE
Media type term unmediated
Media type code n
Source rdamedia
338 ## - CARRIER TYPE
Carrier type term volume
Source rdacarrier
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc. note Includes index.
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note 1. Introduction to regulated clinical trials -- 2. FDA's decision-making process when assessing ambiguous data -- 3. Food effect studies -- 4. Dose modification and dose titration -- 5. Contraindications -- 6. Animal studies -- 7. Drug-drug interactions: part one (small molecule drugs) -- 8. Drug-drug interactions: part two (therapeutic proteins) -- 9. Immunosuppression, drug-induced hypersensitivity reactions, and drug-induced autoimmune reactions -- 10. Drug class analysis -- 11. Relatedness -- 12. Adjudication of clinical data -- 13. Coding -- 14. Pooling.
520 ## - SUMMARY, ETC.
Summary, etc. FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label --
Assigning source See back cover.
610 10 - SUBJECT ADDED ENTRY--CORPORATE NAME
Corporate name or jurisdiction name as entry element United States.
Subordinate unit Food and Drug Administration.
610 17 - SUBJECT ADDED ENTRY--CORPORATE NAME
Corporate name or jurisdiction name as entry element United States.
Subordinate unit Food and Drug Administration.
Source of heading or term fast
Authority record control number or standard number (OCoLC)fst00549734
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Drug approval
General subdivision Government policy
Geographic subdivision United States.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Clinical trials
Geographic subdivision United States
General subdivision Moral and ethical conflicts.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Drug approval
General subdivision Safety regulations
Geographic subdivision United States.
651 #7 - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Geographic name United States.
Source of heading or term fast
Authority record control number or standard number (OCoLC)fst01204155
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Brody, Tom,
Relator term author.
906 ## - LOCAL DATA ELEMENT F, LDF (RLIN)
a 7
b cbc
c copycat
d 2
e ncip
f 20
g y-gencatlg
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme
Koha item type Book
Holdings
Withdrawn status Lost status Source of classification or shelving scheme Damaged status Not for loan Collection code Permanent Location Current Location Shelving location Date acquired Source of acquisition Full call number Barcode Date last seen Copy number Cost, replacement price Price effective from Koha item type
          Non-fiction Medical Library Medical Library On Shelf 2022-04-22 Donation R852.5 BRO 2018 33729004845421 2022-04-22 1 300.00 2022-04-22 Book
            Medical Library Medical Library   2022-06-06   R852.5 BRO 2018 33729000151899 2022-06-06 2   2022-06-06 Book