skip to content
Drug products for clinical trials Preview this item
ClosePreview this item
Checking...

Drug products for clinical trials

Author: Donald C Monkhouse; Charles Carney; Jim Clark
Publisher: New York : Taylor & Francis, 2006.
Series: Drugs and the pharmaceutical sciences, v. 147.
Edition/Format:   eBook : Document : English : 2nd edView all editions and formats
Summary:
Addressing issues at the forefront of interest for the Clinical Trial Materials Professional (CTMP), this Second Edition highlights the most critical concepts related to the planning, manufacturing, packaging, labeling, distribution, reconciliation, and quality and regulatory control of clinical trial materials-offering an authoritative selection of chapters on the current and evolving state of clinical supplies  Read more...
Rating:

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

Subjects
More like this

Find a copy in the library

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

Details

Genre/Form: Electronic books
Additional Physical Format: Print version:
Drug products for clinical trials.
New York : Taylor & Francis, 2006
(DLC) 2005053858
(OCoLC)61129507
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Donald C Monkhouse; Charles Carney; Jim Clark
ISBN: 9780849352768 0849352762
OCLC Number: 143041628
Description: 1 online resource (xvi, 399 pages) : illustrations
Contents: Front cover; Preface; Contents; Contributors; The Clinical Trials Material Professional: A Changing Role; INTRODUCTION; Decline in the Pharmaceutical Industry; FDA Initiatives; ADMINISTRATIVE/ORGANIZATIONAL ROLE Company Structure; Re-Engineering R & D; Project Management; Communication Breakdown; OUTSIDE INFLUENCES Outsourcing; Counterfeiting; Drugs of Abuse; Extemporaneous Compounding; European Regulations; CONCLUSIONS; REFERENCES; Discovery and Formulation Trends for the Clinical Trials Material Professional; DISCOVERY TRENDS Outlook for Drug Discovery; Formulatability and Drugability. High Throughput ScreeningIn Silico Approaches; Pharmacogenomics; Miscellaneous Considerations; PHYSICOCHEMICAL CHARACTERIZATION Rapid Crystallography; Amorphous Solids; Calorimetry; X-Ray Diffraction; Inverse Gas Chromatography; DISSOLUTION AND ABSORPTION Biopharmaceutical Classification System; Metabolism; Regional Absorption; Effect of Food; Solubility Enhancement; ALTERNATE ROUTES OF ADMINISTRATION Inhalation; Colonic; Nasal; Gastro-Retention/Bioadhesives; Depot Formulations; Absorption Enhancers; Transporters; BIOLOGICALS Peptides and Proteins; Pegylation; Monoclonal Antibodies. DRUG DELIVERY/PRODUCTSLife Cycle/Alternate Routes; Combination Products; Injection Devices; Transdermal Systems; Tissue Engineering; Cells; Gene Delivery; Chronotherapeutics; Nanomedicine; CONCLUSIONS; REFERENCES; Manufacturing and Clinical Medicine Trends for the Clinical Trials Material Professional; INTRODUCTION; MANUFACTURING PROCESSES Dearth of New Excipients; Super Critical Fluid Processing; Rapid Prototyping; Electrostatic Deposition; NROBE2; Robots; Hot Melt Extrusion; Orally Dispersing Tablets; Dissolvable Films; Parenteral Processing. MANUFACTURING TRENDS Contract Manufacturing OrganizationsGeneral Manufacturing; Process Analytical Technology (PAT); Process Analyzers; Rapid Microbiology Testing; Active Pharmaceutical Ingredients; Six Sigma; Continuous Processing; INFORMATION TECHNOLOGY; New Electronic Clinical Trial Management Systems; Smart Tags or Radio Frequency Identification (RFID) Tags; Process Analytical Technology; Petaflop and Grid Computing; Predictive Biosimulation; Pervasive Computing; Web-Scale Mining and Advanced Text Analytics; CLINICAL Toxicology; Experimental Medicine; Computerized Data; Remote Monitoring. Conduct of Clinical TrialsDEVELOPMENT CONSIDERATIONS; QSR Compliance; Importance of Patents; CONCLUSIONS: CONSIDERATIONS FOR THE CLINICAL TRIALS MATERIAL PROFESSIONAL; REFERENCES; Quality Assurance Systems for Global Companies; INTRODUCTION; RESEARCH AND DEVELOPMENT QUALITY SYSTEM Good Business Practices; Good Scientific Practices; Regulatory Perspective; GLOBAL QUALITY ASSURANCE FOR CLINICAL SUPPLIES PREPARATION; SUMMARY AND CONCLUSIONS; REFERENCES; Special Facilities for Developing, Manufacturing, and Packaging Potent or Hazardous Drug Products; INTRODUCTION.
Series Title: Drugs and the pharmaceutical sciences, v. 147.
Responsibility: edited by Donald C. Monkhouse, Charles F. Carney, James L. Clark.

Abstract:

Addressing issues at the forefront of interest for the Clinical Trial Materials Professional (CTMP), this Second Edition highlights the most critical concepts related to the planning, manufacturing, packaging, labeling, distribution, reconciliation, and quality and regulatory control of clinical trial materials-offering an authoritative selection of chapters on the current and evolving state of clinical supplies operations by esteemed researchers and consultants in industry.

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


Primary Entity

<http://www.worldcat.org/oclc/143041628> # Drug products for clinical trials
    a schema:CreativeWork, schema:MediaObject, schema:Book ;
    library:oclcnum "143041628" ;
    library:placeOfPublication <http://id.loc.gov/vocabulary/countries/nyu> ;
    library:placeOfPublication <http://dbpedia.org/resource/New_York_City> ; # New York
    schema:about <http://experiment.worldcat.org/entity/work/data/795098683#Topic/medicaments_essais_cliniques> ; # Médicaments--Essais cliniques
    schema:about <http://experiment.worldcat.org/entity/work/data/795098683#Topic/medical_nursing_pharmacology> ; # MEDICAL--Nursing--Pharmacology
    schema:about <http://experiment.worldcat.org/entity/work/data/795098683#Topic/drug_industry_standards> ; # Drug Industry--standards
    schema:about <http://experiment.worldcat.org/entity/work/data/795098683#Topic/quality_control> ; # Quality Control
    schema:about <http://experiment.worldcat.org/entity/work/data/795098683#Topic/medical_pharmacy> ; # MEDICAL--Pharmacy
    schema:about <http://experiment.worldcat.org/entity/work/data/795098683#Topic/clinical_trials_standards> ; # Clinical Trials--standards
    schema:about <http://experiment.worldcat.org/entity/work/data/795098683#Topic/medical_pharmacology> ; # MEDICAL--Pharmacology
    schema:about <http://experiment.worldcat.org/entity/work/data/795098683#Topic/drugs_testing> ; # Drugs--Testing
    schema:about <http://dewey.info/class/615.19/e22/> ;
    schema:about <http://id.loc.gov/authorities/subjects/sh85039755> ; # Drugs--Testing
    schema:about <http://experiment.worldcat.org/entity/work/data/795098683#Topic/medical_drug_guides> ; # MEDICAL--Drug Guides
    schema:bookEdition "2nd ed." ;
    schema:bookFormat schema:EBook ;
    schema:contributor <http://viaf.org/viaf/10136047> ; # Charles F. Carney
    schema:contributor <http://viaf.org/viaf/71682630> ; # Donald C. Monkhouse
    schema:contributor <http://experiment.worldcat.org/entity/work/data/795098683#Person/clark_jim> ; # Jim Clark
    schema:datePublished "2006" ;
    schema:description "Front cover; Preface; Contents; Contributors; The Clinical Trials Material Professional: A Changing Role; INTRODUCTION; Decline in the Pharmaceutical Industry; FDA Initiatives; ADMINISTRATIVE/ORGANIZATIONAL ROLE Company Structure; Re-Engineering R & D; Project Management; Communication Breakdown; OUTSIDE INFLUENCES Outsourcing; Counterfeiting; Drugs of Abuse; Extemporaneous Compounding; European Regulations; CONCLUSIONS; REFERENCES; Discovery and Formulation Trends for the Clinical Trials Material Professional; DISCOVERY TRENDS Outlook for Drug Discovery; Formulatability and Drugability."@en ;
    schema:description "Addressing issues at the forefront of interest for the Clinical Trial Materials Professional (CTMP), this Second Edition highlights the most critical concepts related to the planning, manufacturing, packaging, labeling, distribution, reconciliation, and quality and regulatory control of clinical trial materials-offering an authoritative selection of chapters on the current and evolving state of clinical supplies operations by esteemed researchers and consultants in industry."@en ;
    schema:exampleOfWork <http://worldcat.org/entity/work/id/795098683> ;
    schema:genre "Electronic books"@en ;
    schema:inLanguage "en" ;
    schema:isPartOf <http://experiment.worldcat.org/entity/work/data/795098683#Series/drugs_and_the_pharmaceutical_sciences> ; # Drugs and the pharmaceutical sciences ;
    schema:isSimilarTo <http://www.worldcat.org/oclc/61129507> ;
    schema:name "Drug products for clinical trials"@en ;
    schema:productID "143041628" ;
    schema:publication <http://www.worldcat.org/title/-/oclc/143041628#PublicationEvent/new_york_taylor_&_francis_2006> ;
    schema:publisher <http://experiment.worldcat.org/entity/work/data/795098683#Agent/taylor_&_francis> ; # Taylor & Francis
    schema:url <http://VH7QX3XE2P.search.serialssolutions.com/?V=1.0&L=VH7QX3XE2P&S=JCs&C=TC0000141573&T=marc&tab=BOOKS> ;
    schema:url <https://public.ebookcentral.proquest.com/choice/publicfullrecord.aspx?p=263158> ;
    schema:url <http://www.myilibrary.com?id=61012> ;
    schema:url <https://nls.ldls.org.uk/welcome.html?ark:/81055/vdc_100046437392.0x000001> ;
    schema:url <https://public.ebookcentral.proquest.com/choice/publicfullrecord.aspx?p=1405463> ;
    schema:url <http://www.myilibrary.com?id=61012&ref=toc> ;
    schema:url <http://www.crcnetbase.com/isbn/9780824754624> ;
    schema:url <https://www.taylorfrancis.com/books/e/9780849352768> ;
    schema:url <https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=159093> ;
    schema:url <http://www.crcnetbase.com/isbn/9780849352768> ;
    schema:url <http://site.ebrary.com/id/10143322> ;
    schema:workExample <http://worldcat.org/isbn/9780849352768> ;
    umbel:isLike <http://bnb.data.bl.uk/id/resource/GBB7C6420> ;
    umbel:isLike <http://bnb.data.bl.uk/id/resource/GBA560889> ;
    wdrs:describedby <http://www.worldcat.org/title/-/oclc/143041628> ;
    .


Related Entities

<http://dbpedia.org/resource/New_York_City> # New York
    a schema:Place ;
    schema:name "New York" ;
    .

<http://experiment.worldcat.org/entity/work/data/795098683#Agent/taylor_&_francis> # Taylor & Francis
    a bgn:Agent ;
    schema:name "Taylor & Francis" ;
    .

<http://experiment.worldcat.org/entity/work/data/795098683#Person/clark_jim> # Jim Clark
    a schema:Person ;
    schema:familyName "Clark" ;
    schema:givenName "Jim" ;
    schema:name "Jim Clark" ;
    .

<http://experiment.worldcat.org/entity/work/data/795098683#Series/drugs_and_the_pharmaceutical_sciences> # Drugs and the pharmaceutical sciences ;
    a bgn:PublicationSeries ;
    schema:hasPart <http://www.worldcat.org/oclc/143041628> ; # Drug products for clinical trials
    schema:name "Drugs and the pharmaceutical sciences ;" ;
    .

<http://experiment.worldcat.org/entity/work/data/795098683#Topic/clinical_trials_standards> # Clinical Trials--standards
    a schema:Intangible ;
    schema:name "Clinical Trials--standards"@en ;
    .

<http://experiment.worldcat.org/entity/work/data/795098683#Topic/drug_industry_standards> # Drug Industry--standards
    a schema:Intangible ;
    schema:name "Drug Industry--standards"@en ;
    .

<http://experiment.worldcat.org/entity/work/data/795098683#Topic/medical_drug_guides> # MEDICAL--Drug Guides
    a schema:Intangible ;
    schema:name "MEDICAL--Drug Guides"@en ;
    .

<http://experiment.worldcat.org/entity/work/data/795098683#Topic/medical_nursing_pharmacology> # MEDICAL--Nursing--Pharmacology
    a schema:Intangible ;
    schema:name "MEDICAL--Nursing--Pharmacology"@en ;
    .

<http://experiment.worldcat.org/entity/work/data/795098683#Topic/medical_pharmacology> # MEDICAL--Pharmacology
    a schema:Intangible ;
    schema:name "MEDICAL--Pharmacology"@en ;
    .

<http://experiment.worldcat.org/entity/work/data/795098683#Topic/medical_pharmacy> # MEDICAL--Pharmacy
    a schema:Intangible ;
    schema:name "MEDICAL--Pharmacy"@en ;
    .

<http://experiment.worldcat.org/entity/work/data/795098683#Topic/medicaments_essais_cliniques> # Médicaments--Essais cliniques
    a schema:Intangible ;
    schema:name "Médicaments--Essais cliniques"@fr ;
    .

<http://id.loc.gov/authorities/subjects/sh85039755> # Drugs--Testing
    a schema:Intangible ;
    schema:name "Drugs--Testing"@en ;
    .

<http://viaf.org/viaf/10136047> # Charles F. Carney
    a schema:Person ;
    schema:familyName "Carney" ;
    schema:givenName "Charles F." ;
    schema:givenName "Charles" ;
    schema:name "Charles F. Carney" ;
    .

<http://viaf.org/viaf/71682630> # Donald C. Monkhouse
    a schema:Person ;
    schema:familyName "Monkhouse" ;
    schema:givenName "Donald C." ;
    schema:name "Donald C. Monkhouse" ;
    .

<http://worldcat.org/isbn/9780849352768>
    a schema:ProductModel ;
    schema:isbn "0849352762" ;
    schema:isbn "9780849352768" ;
    .

<http://www.worldcat.org/oclc/61129507>
    a schema:CreativeWork ;
    rdfs:label "Drug products for clinical trials." ;
    schema:description "Print version:" ;
    schema:isSimilarTo <http://www.worldcat.org/oclc/143041628> ; # Drug products for clinical trials
    .


Content-negotiable representations

Close Window

Please sign in to WorldCat 

Don't have an account? You can easily create a free account.