1.

Record Nr.

UNISA990002879670203316

Autore

BOURGET, Paul <1852-1935>

Titolo

Nos actes nous suivent / Paul Bourget

Pubbl/distr/stampa

Paris : Plon, [1927]

Descrizione fisica

v. ; 19 cm

Disciplina

843.9

Collocazione

XV.5. 498/2

Lingua di pubblicazione

Francese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Nota di contenuto

<vol. 2.> : 260 p.

2.

Record Nr.

UNINA9911074369703321

Titolo

Pan American Highways Congress. Message from the President of the United States, transmitting a report by the Secretary of State concerning a Pan American Highways Congress, to meet at Buenos Aires on May 22, 1925, together with copies of letters from the Acting Secretary of Commerce ... January 22 (calendar day, January 24), 1925. -- Referred to the Committee on Foreign Relations and ordered to be printed

Pubbl/distr/stampa

Washington, DC : , : [publisher not identified], , 1925

Descrizione fisica

1 online resource (8 pages)

Collana

Senate document / 68th Congress, 2nd session. Senate ; ; no. 189

[United States congressional serial set] ; ; [serial set no. 8413]

Altri autori (Persone)

CoolidgeCalvin <1872-1933.>

Soggetti

Clergy conferences

Congresses and conventions

International relations

Roads

Legislative materials.

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa



Livello bibliografico

Monografia

Note generali

Batch processed record: Metadata reviewed, not verified. Some fields updated by batch processes.

FDLP item number not assigned.

3.

Record Nr.

UNINA9911098671803321

Titolo

Clinical trials handbook / / edited by Shayne Cox Gad

Pubbl/distr/stampa

Hoboken, NJ, : Wiley, c2009

ISBN

1-282-36844-3

9786612368448

0-470-46636-7

0-470-46635-9

Edizione

[1st ed.]

Descrizione fisica

1 online resource (1247 p.)

Collana

Pharmaceutical Development Series ; ; v.8

Altri autori (Persone)

GadShayne C. <1948->

Disciplina

615.1

615.580724

615/.1

Soggetti

Drugs - Testing

Clinical trials

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Description based upon print version of record.

Nota di bibliografia

Includes bibliographical references and index.

Nota di contenuto

Clinical Trials Handbook; Contents; Preface; Contributors; 1 Introduction to Clinical Trials; 2 Regulatory Requirements for Investigational New Drug; 3 Preclinical Assessment of Safety in Human Subjects; 4 Predicting Human Adverse Drug Reactions from Nonclinical Safety Studies; 5.1 History of Clinical Trial Development and the Pharmaceutical Industry; 5.2 Adaptive Research; 6 Organization and Planning; 7 Process of Data Management; 8 Clinical Trials Data Management; 9.1 Clinical Trials and the Food and Drug Administration; 9.2 Phase I Clinical Trials; 9.3 Phase II Clinical Trials

9.4 Designing and Conducting Phase III Studies9.5 Phase IV: Postmarketing Trials; 9.6 Phase IV and Postmarketing Clinical Trials; 9.7 Regulatory Approval; 9.8 New Paradigm for Analyzing Adverse Drug



Events; 10.1 Clinical Trials in Interventional Cardiology: Focus on XIENCE Drug-Eluting Stent; 10.2 Clinical Trials Involving Oral Diseases; 10.3 Dermatology Clinical Trials; 10.4 Emergency Clinical Trials; 10.5 Gastroenterology; 10.6 Gynecology Randomized Control Trials; 10.7 Special Population Studies (Healthy Patient Studies); 10.8 Musculoskeletal Disorders; 10.9 Oncology

10.10 Pharmacological Treatment Options for Nonexudative and Exudative Age-Related Macular Degeneration10.11 Paediatrics; 10.12 Clinical Trials in Dementia; 10.13 Clinical Trials in Urology; 10.14 Clinical Trials on Cognitive Drugs; 10.15 Bridging Studies in Pharmaceutical Safety Assessment; 10.16 Brief History of Clinical Trials on Viral Vaccines; 11 Methods of Randomization; 12 Randomized Controlled Trials; 13 Cross-Over Designs; 14.1 Biomarkers; 14.2 Biomarkers in Clinical Drug Development: Parallel Analysis of Alzheimer Disease and Multiple Sclerosis; 15 Review Boards

16 Size of Clinical Trials17 Blinding and Placebo; 18 Pharmacology; 19 Modeling and Simulation in Clinical Drug Development; 20 Monitoring; 21 Inference Following Sequential Clinical Trials; 22 Statistical Methods for Analysis of Clinical Trials; 23 Explanatory and Pragmatic Clinical Trials; 24.1 Ethics of Clinical Research in Durg Trials; 24.2 Ethical Issues in Clinical Research; 25 Regulations; 26 Future Challenges in Design and Ethics of Clinical Trials; 27 Proof-of-Principle/Proof-of-Concept Trials in Drug Development; Index

Sommario/riassunto

Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of