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New drug approval process : accelerating global registrations

Author: Richard A Guarino
Publisher: New York : M. Dekker, ©2004.
Series: Drugs and the pharmaceutical sciences, v. 139.
Edition/Format:   Print book : English : 4th edView all editions and formats
Summary:

Clarifying how to develop and market new drugs efficiently and economically for global markets, this text covers the emphasis on over-the-counter drugs in the long-range plans of many companies and  Read more...

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Document Type: Book
All Authors / Contributors: Richard A Guarino
ISBN: 9780824750411 0824750411
OCLC Number: 55589671
Description: xiv, 635 pages : illustrations ; 24 cm.
Contents: Part I : Regulatory practices and procedures of new drug, biologic and device development --
Drug development teams --
Nonclinical drug development --
The investigational new drug application and the investigator's brochure --
General considerations of the new drug application --
The new drug application, content and format --
Abbreviated and supplemental new drug applications --
The biologics license application --
Device legislation and application --
Orphan drugs --
Part II : Clinical research development --
Adverse experiences, adverse reactions, interactions of drugs --
Biostatistics in pharmaceutical product development --
Industry and FDA liasion --
Part III : Specific aspects in the process of new product submissions --
Chemistry, manufacturing, and control requirements of the NDA and ANDA --
Data presentation for FDA submissions --
Preparing for FDA inspections --
Technology change --
The common technical document for the registration of pharmaceutical for human use --
Part IV : Global applications of good clinical practices --
Obligations of the investigator, sponsor, monitor --
Instituitional review board --
Quality assurance --
Managing clinical trials --
The European union directive on good clinical parctice in clinical trials --
HIPAA --
Part V : Effective and new methodologies in expediting new product approvals in the US and European union --
Working with a CRO --
The evolving SMO in the US --
Accelerating new product approvals.
Series Title: Drugs and the pharmaceutical sciences, v. 139.
Responsibility: edited by Richard A. Guarino.

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..."a useful road map to understanding the requirements that a drug product must fulfill to achieve approval." Journal of Medicinal Chemistry "There are very useful formats, brochures, statistics, Read more...

 
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Primary Entity<\/h3>\n
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Guarino<\/span>\n\u00A0\u00A0\u00A0\nschema:copyrightYear<\/a> \"2004<\/span>\" ;\u00A0\u00A0\u00A0\nschema:datePublished<\/a> \"2004<\/span>\" ;\u00A0\u00A0\u00A0\nschema:description<\/a> \"Part I : Regulatory practices and procedures of new drug, biologic and device development -- Drug development teams -- Nonclinical drug development -- The investigational new drug application and the investigator\'s brochure -- General considerations of the new drug application -- The new drug application, content and format -- Abbreviated and supplemental new drug applications -- The biologics license application -- Device legislation and application -- Orphan drugs -- Part II : Clinical research development -- Adverse experiences, adverse reactions, interactions of drugs -- Biostatistics in pharmaceutical product development -- Industry and FDA liasion -- Part III : Specific aspects in the process of new product submissions -- Chemistry, manufacturing, and control requirements of the NDA and ANDA -- Data presentation for FDA submissions -- Preparing for FDA inspections -- Technology change -- The common technical document for the registration of pharmaceutical for human use -- Part IV : Global applications of good clinical practices -- Obligations of the investigator, sponsor, monitor -- Instituitional review board -- Quality assurance -- Managing clinical trials -- The European union directive on good clinical parctice in clinical trials -- HIPAA -- Part V : Effective and new methodologies in expediting new product approvals in the US and European union -- Working with a CRO -- The evolving SMO in the US -- Accelerating new product approvals.<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\nschema:exampleOfWork<\/a> <http:\/\/worldcat.org\/entity\/work\/id\/2044280867<\/a>> ;\u00A0\u00A0\u00A0\nschema:inLanguage<\/a> \"en<\/span>\" ;\u00A0\u00A0\u00A0\nschema:isPartOf<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/2044280867#Series\/drugs_and_the_pharmaceutical_sciences<\/a>> ; # Drugs and the pharmaceutical sciences ;<\/span>\n\u00A0\u00A0\u00A0\nschema:name<\/a> \"New drug approval process : accelerating global registrations<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\nschema:productID<\/a> \"55589671<\/span>\" ;\u00A0\u00A0\u00A0\nschema:publication<\/a> <http:\/\/www.worldcat.org\/title\/-\/oclc\/55589671#PublicationEvent\/new_york_m_dekker_2004<\/a>> ;\u00A0\u00A0\u00A0\nschema:publisher<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/2044280867#Agent\/m_dekker<\/a>> ; # M. 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<http:\/\/dbpedia.org\/resource\/New_York_City<\/a>> # New York<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Place<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"New York<\/span>\" ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/dewey.info\/class\/363.194660973\/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\/2044280867#Agent\/m_dekker<\/a>> # M. Dekker<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nbgn:Agent<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"M. Dekker<\/span>\" ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/2044280867#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\/2044280867#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\/55589671<\/a>> ; # New drug approval process : accelerating global registrations<\/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\/2044280867#Topic\/clinical_trials_as_topic_standards<\/a>> # Clinical Trials as Topic--standards<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Clinical Trials as Topic--standards<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/2044280867#Topic\/drug_approval<\/a>> # Drug Approval<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Drug Approval<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/2044280867#Topic\/drug_evaluation_standards<\/a>> # Drug Evaluation--standards<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Drug Evaluation--standards<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/2044280867#Topic\/drugs_testing_government_policy_united_states<\/a>> # Drugs--Testing--Government policy--United States<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:hasPart<\/a> <http:\/\/id.loc.gov\/authorities\/subjects\/sh85039755<\/a>> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Drugs--Testing--Government policy--United States<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/2044280867#Topic\/drugs_testing_standards<\/a>> # Drugs--Testing--Standards<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:hasPart<\/a> <http:\/\/id.loc.gov\/authorities\/subjects\/sh85039755<\/a>> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Drugs--Testing--Standards<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/2044280867#Topic\/geneesmiddelen<\/a>> # Geneesmiddelen<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Geneesmiddelen<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/2044280867#Topic\/medicaments_autorisation_de_mise_sur_le_marche_etats_unis<\/a>> # M\u00E9dicaments--Autorisation de mise sur le march\u00E9--\u00C9tats-Unis<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"M\u00E9dicaments--Autorisation de mise sur le march\u00E9--\u00C9tats-Unis<\/span>\"@fr<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/2044280867#Topic\/medicaments_essais_cliniques_normes<\/a>> # M\u00E9dicaments--Essais cliniques--Normes<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"M\u00E9dicaments--Essais cliniques--Normes<\/span>\"@fr<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/2044280867#Topic\/medicaments_essais_cliniques_politique_gouvernementale_etats_unis<\/a>> # M\u00E9dicaments--Essais cliniques--Politique gouvernementale--\u00C9tats-Unis<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"M\u00E9dicaments--Essais cliniques--Politique gouvernementale--\u00C9tats-Unis<\/span>\"@fr<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/2044280867#Topic\/new_products_government_policy_united_states<\/a>> # New products--Government policy--United States<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:hasPart<\/a> <http:\/\/id.loc.gov\/authorities\/subjects\/sh85091388<\/a>> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"New products--Government policy--United States<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/2044280867#Topic\/produits_nouveaux_politique_gouvernementale_etats_unis<\/a>> # Produits nouveaux--Politique gouvernementale--\u00C9tats-Unis<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Produits nouveaux--Politique gouvernementale--\u00C9tats-Unis<\/span>\"@fr<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/experiment.worldcat.org\/entity\/work\/data\/2044280867#Topic\/registratie_administratie<\/a>> # Registratie (administratie)<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Registratie (administratie)<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/id.loc.gov\/authorities\/subjects\/sh2009123884<\/a>> # Drug approval--United States<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Drug approval--United States<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/id.loc.gov\/vocabulary\/countries\/nyu<\/a>>\u00A0\u00A0\u00A0\u00A0a \nschema:Place<\/a> ;\u00A0\u00A0\u00A0\ndcterms:identifier<\/a> \"nyu<\/span>\" ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/id.worldcat.org\/fast\/1036899<\/a>> # New products--Government policy<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"New products--Government policy<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/id.worldcat.org\/fast\/1204155<\/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:\/\/id.worldcat.org\/fast\/898661<\/a>> # Drug approval<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Drug approval<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/id.worldcat.org\/fast\/898943<\/a>> # Drugs--Testing--Government policy<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Drugs--Testing--Government policy<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/id.worldcat.org\/fast\/898953<\/a>> # Drugs--Testing--Standards<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Intangible<\/a> ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Drugs--Testing--Standards<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/viaf.org\/viaf\/46932520<\/a>> # Richard A. Guarino<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:Person<\/a> ;\u00A0\u00A0\u00A0\nschema:birthDate<\/a> \"1935<\/span>\" ;\u00A0\u00A0\u00A0\nschema:familyName<\/a> \"Guarino<\/span>\" ;\u00A0\u00A0\u00A0\nschema:givenName<\/a> \"Richard A.<\/span>\" ;\u00A0\u00A0\u00A0\nschema:name<\/a> \"Richard A. Guarino<\/span>\" ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/worldcat.org\/isbn\/9780824750411<\/a>>\u00A0\u00A0\u00A0\u00A0a \nschema:ProductModel<\/a> ;\u00A0\u00A0\u00A0\nschema:isbn<\/a> \"0824750411<\/span>\" ;\u00A0\u00A0\u00A0\nschema:isbn<\/a> \"9780824750411<\/span>\" ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n
<http:\/\/www.worldcat.org\/title\/-\/oclc\/55589671<\/a>>\u00A0\u00A0\u00A0\u00A0a \ngenont:InformationResource<\/a>, genont:ContentTypeGenericResource<\/a> ;\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/www.worldcat.org\/oclc\/55589671<\/a>> ; # New drug approval process : accelerating global registrations<\/span>\n\u00A0\u00A0\u00A0\nschema:dateModified<\/a> \"2019-10-25<\/span>\" ;\u00A0\u00A0\u00A0\nvoid:inDataset<\/a> <http:\/\/purl.oclc.org\/dataset\/WorldCat<\/a>> ;\u00A0\u00A0\u00A0\u00A0.\n\n\n<\/div>\n