skip to content
Covid-19 virus
COVID-19 Resources

Reliable information about the coronavirus (COVID-19) is available from the World Health Organization (current situation, international travel). Numerous and frequently-updated resource results are available from this WorldCat.org search. OCLC’s WebJunction has pulled together information and resources to assist library staff as they consider how to handle coronavirus issues in their communities.

Image provided by: CDC/ Alissa Eckert, MS; Dan Higgins, MAM
FDA's drug review process and the package label : strategies for writing successful FDA submissions Preview this item
ClosePreview this item
Checking...

FDA's drug review process and the package label : strategies for writing successful FDA submissions

Author: Tom Brody
Publisher: Cambridge, Massachusetts : Academic Press, 2018. ©2018
Edition/Format:   eBook : Document : EnglishView all editions and formats
Summary:
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.
Rating:

(not yet rated) 0 with reviews - Be the first.

Subjects
More like this

Find a copy online

Links to this item

Find a copy in the library

&AllPage.SpinnerRetrieving; Finding libraries that hold this item...

Details

Genre/Form: Electronic books
Additional Physical Format: (OCoLC)1001456623
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Tom Brody
ISBN: 0128146486 9780128146484
OCLC Number: 1020001278
Description: 1 online resource (654 pages)
Contents: 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.
Responsibility: Tom Brody.

Abstract:

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.

Reviews

User-contributed reviews
Retrieving GoodReads reviews...
Retrieving DOGObooks reviews...

Tags

Be the first.
Confirm this request

You may have already requested this item. Please select Ok if you would like to proceed with this request anyway.

Linked Data


\n\n

Primary Entity<\/h3>\n
<http:\/\/www.worldcat.org\/oclc\/1020001278<\/a>> # FDA\'s drug review process and the package label : strategies for writing successful FDA submissions<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Book<\/a>, schema:CreativeWork<\/a>, schema:MediaObject<\/a> ;\u00A0\u00A0\u00A0\nlibrary:oclcnum<\/a> \"1020001278<\/span>\" ;\u00A0\u00A0\u00A0\nlibrary:placeOfPublication<\/a> <http:\/\/id.loc.gov\/vocabulary\/countries\/mau<\/a>> ;\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/4664306609#Place\/united_states<\/a>> ; # United States.<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/id.loc.gov\/authorities\/classification\/KF27<\/a>> ;\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/4664306609#Topic\/drug_approval_legislation_&_jurisprudence<\/a>> ; # Drug Approval--legislation & jurisprudence<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/dewey.info\/class\/353.00778\/e23\/<\/a>> ;\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/4664306609#Topic\/drug_approval_safety_regulations_united_states<\/a>> ; # Drug approval--Safety regulations--United States<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/4664306609#Topic\/drug_approval_organization_&_administration<\/a>> ; # Drug Approval--organization & administration<\/span>\n\u00A0\u00A0\u00A0\nschema:author<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/4664306609#Person\/brody_tom<\/a>> ; # Tom Brody<\/span>\n\u00A0\u00A0\u00A0\nschema:bookFormat<\/a> schema:EBook<\/a> ;\u00A0\u00A0\u00A0\nschema:copyrightYear<\/a> \"2018<\/span>\" ;\u00A0\u00A0\u00A0\nschema:datePublished<\/a> \"2018<\/span>\" ;\u00A0\u00A0\u00A0\nschema:description<\/a> \"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.<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\nschema:description<\/a> \"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.<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\nschema:exampleOfWork<\/a> <http:\/\/worldcat.org\/entity\/work\/id\/4664306609<\/a>> ;\u00A0\u00A0\u00A0\nschema:genre<\/a> \"Electronic books<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\nschema:inLanguage<\/a> \"en<\/span>\" ;\u00A0\u00A0\u00A0\nschema:isSimilarTo<\/a> <http:\/\/www.worldcat.org\/oclc\/1001456623<\/a>> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"FDA\'s drug review process and the package label : strategies for writing successful FDA submissions<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\nschema:productID<\/a> \"1020001278<\/span>\" ;\u00A0\u00A0\u00A0\nschema:url<\/a> <http:\/\/liverpool.idm.oclc.org\/login?url=https:\/\/www.sciencedirect.com\/science\/book\/9780128146477<\/a>> ;\u00A0\u00A0\u00A0\nschema:url<\/a> <https:\/\/www.sciencedirect.com\/science\/book\/9780128146477<\/a>> ;\u00A0\u00A0\u00A0\nschema:url<\/a> <http:\/\/0-www.sciencedirect.com.pugwash.lib.warwick.ac.uk\/science\/book\/9780128146477<\/a>> ;\u00A0\u00A0\u00A0\nschema:url<\/a> <http:\/\/lib.myilibrary.com?id=1052599<\/a>> ;\u00A0\u00A0\u00A0\nschema:url<\/a> <https:\/\/login.proxy.bib.uottawa.ca\/login?url=https:\/\/www.sciencedirect.com\/science\/book\/9780128146477<\/a>> ;\u00A0\u00A0\u00A0\nschema:url<\/a> <http:\/\/dproxy.library.dc-uoit.ca\/login?url=https:\/\/www.sciencedirect.com\/science\/book\/9780128146477<\/a>> ;\u00A0\u00A0\u00A0\nschema:workExample<\/a> <http:\/\/worldcat.org\/isbn\/9780128146484<\/a>> ;\u00A0\u00A0\u00A0\nwdrs:describedby<\/a> <http:\/\/www.worldcat.org\/title\/-\/oclc\/1020001278<\/a>> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n\n

Related Entities<\/h3>\n
<http:\/\/0-www.sciencedirect.com.pugwash.lib.warwick.ac.uk\/science\/book\/9780128146477<\/a>>\u00A0\u00A0\u00A0\nrdfs:comment<\/a> \"Connect to ScienceDirect e-book<\/span>\" ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/dewey.info\/class\/353.00778\/e23\/<\/a>>\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/dproxy.library.dc-uoit.ca\/login?url=https:\/\/www.sciencedirect.com\/science\/book\/9780128146477<\/a>>\u00A0\u00A0\u00A0\nrdfs:comment<\/a> \"eBook available for Durham College via Elsevier. Click link to access<\/span>\" ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/4664306609#Person\/brody_tom<\/a>> # Tom Brody<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Person<\/a> ;\u00A0\u00A0\u00A0\nschema:familyName<\/a> \"Brody<\/span>\" ;\u00A0\u00A0\u00A0\nschema:givenName<\/a> \"Tom<\/span>\" ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Tom Brody<\/span>\" ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/4664306609#Place\/united_states<\/a>> # United States.<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Place<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"United States.<\/span>\" ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/4664306609#Topic\/drug_approval_legislation_&_jurisprudence<\/a>> # Drug Approval--legislation & jurisprudence<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Drug Approval--legislation & jurisprudence<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/4664306609#Topic\/drug_approval_organization_&_administration<\/a>> # Drug Approval--organization & administration<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Drug Approval--organization & administration<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/4664306609#Topic\/drug_approval_safety_regulations_united_states<\/a>> # Drug approval--Safety regulations--United States<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Drug approval--Safety regulations--United States<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/id.loc.gov\/authorities\/classification\/KF27<\/a>>\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/id.loc.gov\/vocabulary\/countries\/mau<\/a>>\u00A0\u00A0\u00A0\u00A0a \nschema:Place<\/a> ;\u00A0\u00A0\u00A0\ndcterms:identifier<\/a> \"mau<\/span>\" ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/lib.myilibrary.com?id=1052599<\/a>>\u00A0\u00A0\u00A0\nrdfs:comment<\/a> \"Connect to MyiLibrary resource.<\/span>\" ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/liverpool.idm.oclc.org\/login?url=https:\/\/www.sciencedirect.com\/science\/book\/9780128146477<\/a>>\u00A0\u00A0\u00A0\nrdfs:comment<\/a> \"\"Go View this e-book online<\/span>\" ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/worldcat.org\/isbn\/9780128146484<\/a>>\u00A0\u00A0\u00A0\u00A0a \nschema:ProductModel<\/a> ;\u00A0\u00A0\u00A0\nschema:isbn<\/a> \"0128146486<\/span>\" ;\u00A0\u00A0\u00A0\nschema:isbn<\/a> \"9780128146484<\/span>\" ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/www.worldcat.org\/oclc\/1001456623<\/a>>\u00A0\u00A0\u00A0\u00A0a \nschema:CreativeWork<\/a> ;\u00A0\u00A0\u00A0\nschema:isSimilarTo<\/a> <http:\/\/www.worldcat.org\/oclc\/1020001278<\/a>> ; # FDA\'s drug review process and the package label : strategies for writing successful FDA submissions<\/span>\n\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/www.worldcat.org\/title\/-\/oclc\/1020001278<\/a>>\u00A0\u00A0\u00A0\u00A0a \ngenont:InformationResource<\/a>, genont:ContentTypeGenericResource<\/a> ;\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/www.worldcat.org\/oclc\/1020001278<\/a>> ; # FDA\'s drug review process and the package label : strategies for writing successful FDA submissions<\/span>\n\u00A0\u00A0\u00A0\nschema:dateModified<\/a> \"2020-03-27<\/span>\" ;\u00A0\u00A0\u00A0\nvoid:inDataset<\/a> <http:\/\/purl.oclc.org\/dataset\/WorldCat<\/a>> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n\n

Content-negotiable representations<\/p>\n