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The pharmaceutical regulatory process

Author: Ira R Berry
Publisher: New York : Marcel Dekker, 2005.
Series: Drugs and the pharmaceutical sciences, v. 144.
Edition/Format:   Print book : EnglishView all editions and formats
Summary:

A tool to navigate and understand the pharmaceutical regulatory framework. Covering the procedures utilized by pharmaceutical companies for regulatory compliance, this book describes the history and  Read more...

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Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: Ira R Berry
ISBN: 0824754646 9780824754648
OCLC Number: 57434176
Description: xiii, 711 pages : illustrations ; 25 cm.
Contents: Pharmaceutical regulation before and after the food, drug, and cosmetic act / John P. Swann --
The new drug-approval process-before and after 1962 / Michael P. Peskoe --
FDA regulation of biological products / James N. Czaban and Natasha Leskovsek --
Generic drug approval process: pre-1984 history concerning generic drugs / David L. Rosen --
Generic drug approval process, post-1984: Hatch-Waxman reform / Marc S. Gross [and others] --
Food and drug administration modernization act / Arthur Y. Tsien and Patricia E. Pahl --
FDA Antibiotic regulatory scheme: then and now / Irving L. Wiesen --
Pioneer and generic drugs: balance between product life cycle extension and anticompetitive behavior / Robert G. Pinco and Barbara A. Binzak --
The influence of the prescription drug user fee act on the approval process / Marc J. Scheineson --
Clinical research requirements for new drug applications / Gary Yingling and Ann Begly --
Active pharmaceutical ingredients / Max S. Lazar --
Obtaining approval of new drug applications and abbreviated new drug applications from a chemistry, manufacturing, and controls perspective / Dhiren N. Shah --
Obtaining approval of a generic drug / Loren Gelber --
Current good manufacturing practice and the drug approval process / Nicholas Buhay --
CMC post-approval regulatory affairs: constantly managing change / Leo J. Lucisano and Kevin A. Miller --
The influence of the USP on the drug approval process / Edward M. Cohen --
Ways and means to U.S. registration of foreign drugs / Alberto Grignolo [and others] --
Common techinical document-quality (M4-Q): one regulatory participant's perspective / Ubrani V. Venkataram --
21 CFR part 11 compliance and beyond / Richard L. Burcham --
Marketing and advertising/promotion: the impact of government regulations / Daniel Glassman, Philip W. McGinn, Jr., and Gene Goldberg --
Approval and marketing of nonprescription or OTC human drugs / William J. Mead.
Series Title: Drugs and the pharmaceutical sciences, v. 144.
Responsibility: edited by Ira R. Berry.
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Primary Entity<\/h3>\n
<http:\/\/www.worldcat.org\/oclc\/57434176<\/a>> # The pharmaceutical regulatory process<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Book<\/a>, schema:CreativeWork<\/a> ;\u00A0\u00A0\u00A0\nlibrary:oclcnum<\/a> \"57434176<\/span>\" ;\u00A0\u00A0\u00A0\nlibrary:placeOfPublication<\/a> <http:\/\/dbpedia.org\/resource\/New_York_City<\/a>> ; # New York<\/span>\n\u00A0\u00A0\u00A0\nlibrary:placeOfPublication<\/a> <http:\/\/id.loc.gov\/vocabulary\/countries\/nyu<\/a>> ;\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Topic\/pharmaceutical_preparations_standards<\/a>> ; # Pharmaceutical Preparations--standards<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Topic\/drugs_law_and_legislation<\/a>> ; # Drugs--Law and legislation<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Topic\/pharmacy_law_and_legislation<\/a>> ; # Pharmacy--Law and legislation<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Topic\/medicaments_droit_etats_unis<\/a>> ; # M\u00E9dicaments--Droit--\u00C9tats-Unis<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/id.loc.gov\/authorities\/subjects\/sh2008109175<\/a>> ; # Pharmacy--Law and legislation--United States<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Topic\/regulering<\/a>> ; # Regulering<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Topic\/drug_and_narcotic_control_legislation_&_jurisprudence<\/a>> ; # Drug and Narcotic Control--legislation & jurisprudence<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Topic\/farmacie<\/a>> ; # Farmacie<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/id.loc.gov\/authorities\/subjects\/sh2008102437<\/a>> ; # Drugs--Law and legislation--United States<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Topic\/guideline_adherence_legislation_&_jurisprudence<\/a>> ; # Guideline Adherence--legislation & jurisprudence<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/id.loc.gov\/authorities\/classification\/K3636<\/a>> ;\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Place\/united_states<\/a>> ; # United States.<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/dewey.info\/class\/344.7304233\/e22\/<\/a>> ;\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/id.loc.gov\/authorities\/classification\/KF2036<\/a>> ;\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Topic\/pharmacie_droit_etats_unis<\/a>> ; # Pharmacie--Droit--\u00C9tats-Unis<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Topic\/wetgeving<\/a>> ; # Wetgeving<\/span>\n\u00A0\u00A0\u00A0\nschema:bookFormat<\/a> bgn:PrintBook<\/a> ;\u00A0\u00A0\u00A0\nschema:contributor<\/a> <http:\/\/viaf.org\/viaf\/71463364<\/a>> ; # Ira R. Berry<\/span>\n\u00A0\u00A0\u00A0\nschema:datePublished<\/a> \"2005<\/span>\" ;\u00A0\u00A0\u00A0\nschema:description<\/a> \"Pharmaceutical regulation before and after the food, drug, and cosmetic act \/ John P. Swann -- The new drug-approval process-before and after 1962 \/ Michael P. Peskoe -- FDA regulation of biological products \/ James N. Czaban and Natasha Leskovsek -- Generic drug approval process: pre-1984 history concerning generic drugs \/ David L. Rosen -- Generic drug approval process, post-1984: Hatch-Waxman reform \/ Marc S. Gross [and others] -- Food and drug administration modernization act \/ Arthur Y. Tsien and Patricia E. Pahl -- FDA Antibiotic regulatory scheme: then and now \/ Irving L. Wiesen -- Pioneer and generic drugs: balance between product life cycle extension and anticompetitive behavior \/ Robert G. Pinco and Barbara A. Binzak -- The influence of the prescription drug user fee act on the approval process \/ Marc J. Scheineson -- Clinical research requirements for new drug applications \/ Gary Yingling and Ann Begly -- Active pharmaceutical ingredients \/ Max S. Lazar -- Obtaining approval of new drug applications and abbreviated new drug applications from a chemistry, manufacturing, and controls perspective \/ Dhiren N. Shah -- Obtaining approval of a generic drug \/ Loren Gelber -- Current good manufacturing practice and the drug approval process \/ Nicholas Buhay -- CMC post-approval regulatory affairs: constantly managing change \/ Leo J. Lucisano and Kevin A. Miller -- The influence of the USP on the drug approval process \/ Edward M. Cohen -- Ways and means to U.S. registration of foreign drugs \/ Alberto Grignolo [and others] -- Common techinical document-quality (M4-Q): one regulatory participant\'s perspective \/ Ubrani V. Venkataram -- 21 CFR part 11 compliance and beyond \/ Richard L. Burcham -- Marketing and advertising\/promotion: the impact of government regulations \/ Daniel Glassman, Philip W. McGinn, Jr., and Gene Goldberg -- Approval and marketing of nonprescription or OTC human drugs \/ William J. 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<http:\/\/dewey.info\/class\/344.7304233\/e22\/<\/a>>\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Agent\/marcel_dekker<\/a>> # Marcel Dekker<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nbgn:Agent<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Marcel Dekker<\/span>\" ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#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\/9658005608#Series\/drugs_and_the_pharmaceutical_sciences<\/a>> # Drugs and the pharmaceutical sciences ;<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nbgn:PublicationSeries<\/a> ;\u00A0\u00A0\u00A0\nschema:hasPart<\/a> <http:\/\/www.worldcat.org\/oclc\/57434176<\/a>> ; # The pharmaceutical regulatory process<\/span>\n\u00A0\u00A0\u00A0\nschema:name<\/a> \"Drugs and the pharmaceutical sciences ;<\/span>\" ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Topic\/drug_and_narcotic_control_legislation_&_jurisprudence<\/a>> # Drug and Narcotic Control--legislation & jurisprudence<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Drug and Narcotic Control--legislation & jurisprudence<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Topic\/drugs_law_and_legislation<\/a>> # Drugs--Law and legislation<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Drugs--Law and legislation<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Topic\/farmacie<\/a>> # Farmacie<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Farmacie<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Topic\/guideline_adherence_legislation_&_jurisprudence<\/a>> # Guideline Adherence--legislation & jurisprudence<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Guideline Adherence--legislation & jurisprudence<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Topic\/medicaments_droit_etats_unis<\/a>> # M\u00E9dicaments--Droit--\u00C9tats-Unis<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"M\u00E9dicaments--Droit--\u00C9tats-Unis<\/span>\"@fr<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Topic\/pharmaceutical_preparations_standards<\/a>> # Pharmaceutical Preparations--standards<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Pharmaceutical Preparations--standards<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Topic\/pharmacie_droit_etats_unis<\/a>> # Pharmacie--Droit--\u00C9tats-Unis<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Pharmacie--Droit--\u00C9tats-Unis<\/span>\"@fr<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Topic\/pharmacy_law_and_legislation<\/a>> # Pharmacy--Law and legislation<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Pharmacy--Law and legislation<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Topic\/regulering<\/a>> # Regulering<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Regulering<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Topic\/wetgeving<\/a>> # Wetgeving<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Wetgeving<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
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<http:\/\/id.loc.gov\/authorities\/subjects\/sh2008109175<\/a>> # Pharmacy--Law and legislation--United States<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Pharmacy--Law and legislation--United States<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
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<http:\/\/viaf.org\/viaf\/71463364<\/a>> # Ira R. Berry<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Person<\/a> ;\u00A0\u00A0\u00A0\nschema:birthDate<\/a> \"1942<\/span>\" ;\u00A0\u00A0\u00A0\nschema:familyName<\/a> \"Berry<\/span>\" ;\u00A0\u00A0\u00A0\nschema:givenName<\/a> \"Ira R.<\/span>\" ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Ira R. Berry<\/span>\" ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
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<http:\/\/www.worldcat.org\/title\/-\/oclc\/57434176<\/a>>\u00A0\u00A0\u00A0\u00A0a \ngenont:InformationResource<\/a>, genont:ContentTypeGenericResource<\/a> ;\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/www.worldcat.org\/oclc\/57434176<\/a>> ; # The pharmaceutical regulatory process<\/span>\n\u00A0\u00A0\u00A0\nschema:dateModified<\/a> \"2020-07-02<\/span>\" ;\u00A0\u00A0\u00A0\nvoid:inDataset<\/a> <http:\/\/purl.oclc.org\/dataset\/WorldCat<\/a>> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/www.worldcat.org\/title\/-\/oclc\/57434176#PublicationEvent\/new_york_marcel_dekker_2005<\/a>>\u00A0\u00A0\u00A0\u00A0a \nschema:PublicationEvent<\/a> ;\u00A0\u00A0\u00A0\nschema:location<\/a> <http:\/\/dbpedia.org\/resource\/New_York_City<\/a>> ; # New York<\/span>\n\u00A0\u00A0\u00A0\nschema:organizer<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/9658005608#Agent\/marcel_dekker<\/a>> ; # Marcel Dekker<\/span>\n\u00A0\u00A0\u00A0\nschema:startDate<\/a> \"2005<\/span>\" ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n\n

Content-negotiable representations<\/p>\n