Literature DB >> 11656783

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) adopts Consolidated Guideline on Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use.

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Abstract

Entities:  

Keywords:  Biomedical and Behavioral Research; International Conference on Harmonization; Legal Approach

Mesh：

Substances：

Year:  1997        PMID： 11656783

Source DB:  PubMed          Journal:  Int Dig Health Legis        ISSN： 0020-6563


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  50 in total

Review 1.  Ethics and research in critical care.

Authors:  Henry J Silverman; Francois Lemaire
Journal:  Intensive Care Med       Date:  2006-08-08       Impact factor: 17.440

2.  An Evaluation of the Middle East Research Training Initiative Tool in Assessing Effective Functioning of Research Ethics Committees.

Authors:  Walter Jaoko; Elizabeth Bukusi; Arlene M Davis
Journal:  J Empir Res Hum Res Ethics       Date:  2016-09-18       Impact factor: 1.742

3.  Bayesian Population Model of the Pharmacokinetics of Venetoclax in Combination with Rituximab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Results from the Phase III MURANO Study.

Authors:  Rong Deng; Leonid Gibiansky; Tong Lu; Priya Agarwal; Hao Ding; Xiaobin Li; Smita Kshirsagar; Dan Lu; Chunze Li; Sandhya Girish; Jue Wang; Michelle Boyer; Kathryn Humphrey; Kevin J Freise; Ahmed Hamed Salem; John F Seymour; Arnon P Kater; Dale Miles
Journal:  Clin Pharmacokinet       Date:  2019-12       Impact factor: 6.447

4.  Efficacy and Safety of Pembrolizumab Plus Docetaxel vs Docetaxel Alone in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer: The PROLUNG Phase 2 Randomized Clinical Trial.

Authors:  Oscar Arrieta; Feliciano Barrón; Laura Alejandra Ramírez-Tirado; Zyanya Lucia Zatarain-Barrón; Andrés F Cardona; Diego Díaz-García; Masao Yamamoto Ramos; Beatriz Mota-Vega; Amir Carmona; Marco Polo Peralta Álvarez; Yolanda Bautista; Fernando Aldaco; Raquel Gerson; Christian Rolfo; Rafael Rosell
Journal:  JAMA Oncol       Date:  2020-06-01       Impact factor: 31.777

5.  Venetoclax plus R- or G-CHOP in non-Hodgkin lymphoma: results from the CAVALLI phase 1b trial.

Authors:  Andrew D Zelenetz; Gilles Salles; Kylie D Mason; Carla Casulo; Steven Le Gouill; Laurie H Sehn; Herve Tilly; Guillaume Cartron; Martine E D Chamuleau; Andre Goy; Constantine S Tam; Pieternella J Lugtenburg; Adam M Petrich; Arijit Sinha; Divya Samineni; Sylvia Herter; Ellen Ingalla; Edith Szafer-Glusman; Christian Klein; Deepak Sampath; Martin Kornacker; Mehrdad Mobasher; Franck Morschhauser
Journal:  Blood       Date:  2019-03-08       Impact factor: 22.113

Review 6.  Nutrition support in hospitalised adults at nutritional risk.

Authors:  Joshua Feinberg; Emil Eik Nielsen; Steven Kwasi Korang; Kirstine Halberg Engell; Marie Skøtt Nielsen; Kang Zhang; Maria Didriksen; Lisbeth Lund; Niklas Lindahl; Sara Hallum; Ning Liang; Wenjing Xiong; Xuemei Yang; Pernille Brunsgaard; Alexandre Garioud; Sanam Safi; Jane Lindschou; Jens Kondrup; Christian Gluud; Janus C Jakobsen
Journal:  Cochrane Database Syst Rev       Date:  2017-05-19

7.  Development of an accessible self-assessment tool for research ethics committees in developing countries.

Authors:  Hany Sleem; Rehab Abdelhai Ahmed Abdelhai; Imad Al-Abdallat; Mohammed Al-Naif; Hala Mansour Gabr; Et-Taher Kehil; Bakr Bin Sadiq; Reham Yousri; Dyaeldin Elsayed; Suad Sulaiman; Henry Silverman
Journal:  J Empir Res Hum Res Ethics       Date:  2010-09       Impact factor: 1.742

8.  Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial.

Authors:  S S Hassan; R Romero; D Vidyadhari; S Fusey; J K Baxter; M Khandelwal; J Vijayaraghavan; Y Trivedi; P Soma-Pillay; P Sambarey; A Dayal; V Potapov; J O'Brien; V Astakhov; O Yuzko; W Kinzler; B Dattel; H Sehdev; L Mazheika; D Manchulenko; M T Gervasi; L Sullivan; A Conde-Agudelo; J A Phillips; G W Creasy
Journal:  Ultrasound Obstet Gynecol       Date:  2011-06-15       Impact factor: 7.299

9.  Effect of armodafinil on cortical activity and working memory in patients with residual excessive sleepiness associated with CPAP-Treated OSA: a multicenter fMRI study.

Authors:  Douglas N Greve; Stephen P Duntley; Linda Larson-Prior; Andrew D Krystal; Michele T Diaz; Sean P A Drummond; Stephen G Thein; Clete A Kushida; Ronghua Yang; Robert J Thomas
Journal:  J Clin Sleep Med       Date:  2014-02-15       Impact factor: 4.062

10.  Differential functional patterns of memory CD4+ and CD8+ T-cells from volunteers immunized with Ty21a typhoid vaccine observed using a recombinant Escherichia coli system expressing S. Typhi proteins.

Authors:  Rosângela Salerno-Gonçalves; Hervé Tettelin; David Luo; Qin Guo; Matthew T Ardito; William D Martin; Anne S De Groot; Marcelo B Sztein
Journal:  Vaccine       Date:  2019-10-16       Impact factor: 3.641
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