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Contract Research and Development Organizations-Their History, Selection, and Utilization / / by Shayne C. Gad, Charles B. Spainhour, David G. Serota
Contract Research and Development Organizations-Their History, Selection, and Utilization / / by Shayne C. Gad, Charles B. Spainhour, David G. Serota
Autore Gad Shayne C
Edizione [1st ed. 2020.]
Pubbl/distr/stampa Cham : , : Springer International Publishing : , : Imprint : Springer, , 2020
Descrizione fisica 1 online resource (XIII, 519 p. 19 illus., 1 illus. in color.)
Disciplina 658.57
Soggetto topico Pharmacology
Pharmacy
Pharmacology/Toxicology
Literatura científica
Investigació
Contractes de recerca i desenvolupament
Soggetto genere / forma Llibres electrònics
ISBN 3-030-43073-1
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Introduction -- History of CROs: Including CRO Snapshots and a CRO Genealogy Chart -- The Pharmaceutical Development Process & Testing Requirements -- The Medical Device Development Process & Testing Requirements -- Functions and Types of CROs -- Labs in China and India -- Selection of CROs -- Study Directors and PIs -- Nuts and Bolts of Study Performance SCG/CBS -- Electronic Reporting Requirements (SEND & eCTD) -- Study and Project Monitoring -- Contracting, Pricing, and Cost of Works Performed by CROs -- Consultants and their Role -- Building Relationships: Maximizing your return on Expectations with a CRO -- Common Problems and their Solutions -- Appendices: A Toxicology Labs B Medical Device Labs C Phase I Labs D Analytical Labs E GMP Contract Facilities F Formulation G Dosage Forms H Clinical Testing I Regulatory Services J Forms and Checklists -- K Specialized Services -- L Consultants Known to be In-Practice -- Index. .
Record Nr. UNINA-9910416106103321
Gad Shayne C  
Cham : , : Springer International Publishing : , : Imprint : Springer, , 2020
Materiale a stampa
Lo trovi qui: Univ. Federico II
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How to Perform a Systematic Literature Review : A Guide for Healthcare Researchers, Practitioners and Students / / by Edward Purssell, Niall McCrae
How to Perform a Systematic Literature Review : A Guide for Healthcare Researchers, Practitioners and Students / / by Edward Purssell, Niall McCrae
Autore Purssell Edward
Edizione [1st ed. 2020.]
Pubbl/distr/stampa Cham : , : Springer International Publishing : , : Imprint : Springer, , 2020
Descrizione fisica 1 online resource (vii, 188 p. 19 illus., 12 illus. in color.)
Disciplina 610.73072
Soggetto topico Nursing - Research
Nursing - Study and teaching
Research - Methodology
Nursing Research
Nursing Education
Research Skills
Literatura científica
Investigació mèdica
Soggetto genere / forma Llibres electrònics
ISBN 3-030-49672-4
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Introduction -- A brief history of the systematic review -- The aim and scope of a systematic review: a logical approach, developing a question -- Systematic reviews/other types of review -- Searching for literature -- Screening search results: a 1-2-3 approach -- Critical appraisal: assessing the quality of studies -- Meta-analysis: reviewing quantitative studies -- Metasynthesis: reviewing qualitative studies -- Mixed-method synthesis -- Meaning and implications -- Making an impact -- Appendices -- Glossary.
Record Nr. UNINA-9910416135103321
Purssell Edward  
Cham : , : Springer International Publishing : , : Imprint : Springer, , 2020
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Peer review and manuscript management in scientific journals : guidelines for good practice / / by Irene Hames
Peer review and manuscript management in scientific journals : guidelines for good practice / / by Irene Hames
Autore Hames Irene
Pubbl/distr/stampa Malden, MA ; ; Oxford, : Blackwell Pub., 2007
Descrizione fisica 1 online resource (308 p.)
Disciplina 070.4/495
Soggetto topico Scientific literature - Evaluation
Science - Evaluation
Technical writing - Evaluation - Analysis
Peer review
Science - United States - Information services
Avaluació d'experts
Literatura científica
Revistes
Redacció d'escrits tècnics
Soggetto genere / forma Llibres electrònics
ISBN 9786611322052
9781281322050
1281322059
9780470750803
0470750804
9780470750261
047075026X
Classificazione 02.13
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Peer Review and Manuscript Management in Scientific Journals: Guidelines for Good Practice; Contents; Foreword by Robert Campbell and Sally Morris; Preface; Chapter 1: Introduction; What should peer review do?; What does peer review assume?; What is this book trying to achieve?; Chapter 2: The peer-review process - how to get going; The basic process; The people involved in running the peer-review process; Office organization; Choice of system and procedures; Record keeping; Systems available; Chapter 3: Manuscript submission and initial checks on completeness and suitability
Submission guidance to authorsJournal scope and editorial policy; Manuscript presentation; Manuscript submission; Checking and logging of submitted manuscripts; Transfer to editor; Initial assessment of suitability and rejection without external review; Manuscripts with language problems; Chapter 4: The full review process; Identifying and selecting appropriate reviewers; Reviewer information; How to go about identifying and selecting reviewers; Finding reviewers; To invite or not?; Inviting reviewers; Responses to invitations to review
Getting the manuscript and associated material to the reviewersInformation reviewers will require; Associated material needed by reviewers; Monitoring review progress; Reminding and chasing reviewers; Problems during review; Reviewers not returning reviews; Receiving and checking of returned reviews; Checking of reviews; The ethics of amending reviewer reports for authors; The 'ideal' report; Back-to-back manuscripts; Dealing with enquiries on manuscript status; Chapter 5: The decision-making process for reviewed manuscripts; The organizational structure for decision making
The decision-making processDivided opinions from reviewers; The decisions that can be made; Checks to be made before communicating decisions to authors; Communicating the decision to the authors; Rebuttals and appeals from authors; Dealing with revisions; Dealing with resubmissions; Problems with resubmissions; Acceptance; Decision making to consistent standards and the problem of availability of space; Special considerations in decision making: dual-use research and the possible misuse of information; Chapter 6: Moving to online submission and review; How do you choose an online system?
How to prepare to move to online workingEvaluation of current workflow and responsibilities; Specification design for the journal; Questions and text options on the site; Preparation of editorial correspondence for the online site; Health and safety issues; Training and support; Data transfer; The launch and transition period; What to expect after going live online; Impact on submission numbers; Impact on the quality of submissions; Impact on geographical origin of submissions; Impact on reviewing and administration times; Problems that may be encountered and how to deal with them
Online systems are never closed
Record Nr. UNINA-9911019252703321
Hames Irene  
Malden, MA ; ; Oxford, : Blackwell Pub., 2007
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Springer science reviews
Springer science reviews
Pubbl/distr/stampa [Basel] : , : Springer International Publishing
Disciplina 570.5
Soggetto topico Science
Life sciences
Medical sciences
Sciences
Sciences de la vie
Sciences de la santé
Ciència
Literatura científica
Soggetto genere / forma Periodicals
Revistes electròniques.
ISSN 2213-7793
Formato Materiale a stampa
Livello bibliografico Periodico
Lingua di pubblicazione eng
Altri titoli varianti Science reviews
Record Nr. UNINA-9910874542003321
[Basel] : , : Springer International Publishing
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui