Literature DB >> 32727913

Scientific considerations for global drug development.

Jennifer L Wilson1, Kit Wun Kathy Cheung1, Lawrence Lin1, Elizabeth A E Green1, Analia I Porrás2, Ling Zou1, David Mukanga3, Paul A Akpa4, Delese Mimi Darko5, Rae Yuan6, Sheng Ding7,8, Wiltshire C N Johnson9, Howard A Lee10,11, Emer Cooke12, Carl C Peck1,13, Steven E Kern3, Dan Hartman3, Yoshikazu Hayashi14, Peter W Marks15, Russ B Altman16, Murray M Lumpkin3, Kathleen M Giacomini17, Terrence F Blaschke18.   

Abstract

Requiring regional or in-country confirmatory clinical trials before approval of drugs already approved elsewhere delays access to medicines in low- and middle-income countries and raises drug costs. Here, we discuss the scientific and technological advances that may reduce the need for in-country or in-region clinical trials for drugs approved in other countries and limitations of these advances that could necessitate in-region clinical studies.
Copyright © 2020 The Authors, some rights reserved; exclusive licensee American Association for the Advancement of Science. No claim to original U.S. Government Works.

Entities:  

Year:  2020        PMID： 32727913      PMCID： PMC8158457          DOI： 10.1126/scitranslmed.aax2550

Source DB:  PubMed          Journal:  Sci Transl Med        ISSN： 1946-6234            Impact factor:   17.956


  28 in total

1.  Enhancing pediatric clinical trial feasibility through the use of Bayesian statistics.

Authors:  Robin A Huff; Jeff D Maca; Mala Puri; Earl W Seltzer
Journal:  Pediatr Res       Date:  2017-08-16       Impact factor: 3.756

2.  Optimizing the Use of Electronic Data Sources in Clinical Trials: The Technology Landscape.

Authors:  Ed Kellar; Susan Bornstein; Aleny Caban; Michelle Crouthamel; Catherine Celingant; Patricia A McIntire; Chrissy Johnson; Prasann Mehta; Vanja Sikirica; Brett Wilson
Journal:  Ther Innov Regul Sci       Date:  2017-07-11       Impact factor: 1.778

Review 3.  Understanding drug interactions with St John's wort (Hypericum perforatum L.): impact of hyperforin content.

Authors:  Sigrun Chrubasik-Hausmann; Julia Vlachojannis; Andrew J McLachlan
Journal:  J Pharm Pharmacol       Date:  2018-02-07       Impact factor: 3.765

Review 4.  The Nature and Evolution of Genomic Diversity in the Mycobacterium tuberculosis Complex.

Authors:  Daniela Brites; Sebastien Gagneux
Journal:  Adv Exp Med Biol       Date:  2017       Impact factor: 2.622

Review 5.  Clinical Pharmacogenetics Implementation Consortium guidelines for cytochrome P450 2D6 genotype and codeine therapy: 2014 update.

Authors:  K R Crews; A Gaedigk; H M Dunnenberger; J S Leeder; T E Klein; K E Caudle; C E Haidar; D D Shen; J T Callaghan; S Sadhasivam; C A Prows; E D Kharasch; T C Skaar
Journal:  Clin Pharmacol Ther       Date:  2014-01-23       Impact factor: 6.875

6.  Global distribution and prevalence of hepatitis C virus genotypes.

Authors:  Jane P Messina; Isla Humphreys; Abraham Flaxman; Anthony Brown; Graham S Cooke; Oliver G Pybus; Eleanor Barnes
Journal:  Hepatology       Date:  2014-07-28       Impact factor: 17.425

Review 7.  Pharmacokinetic and pharmacodynamic considerations in antimalarial dose optimization.

Authors:  Nicholas J White
Journal:  Antimicrob Agents Chemother       Date:  2013-09-03       Impact factor: 5.191

Review 8.  A Historical Overview of the Classification, Evolution, and Dispersion of Leishmania Parasites and Sandflies.

Authors:  Mohammad Akhoundi; Katrin Kuhls; Arnaud Cannet; Jan Votýpka; Pierre Marty; Pascal Delaunay; Denis Sereno
Journal:  PLoS Negl Trop Dis       Date:  2016-03-03

9.  The quality of registration of clinical trials: still a problem.

Authors:  Roderik F Viergever; Ghassan Karam; Andreas Reis; Davina Ghersi
Journal:  PLoS One       Date:  2014-01-10       Impact factor: 3.240

Review 10.  Critical concepts in adaptive clinical trials.

Authors:  Jay Jh Park; Kristian Thorlund; Edward J Mills
Journal:  Clin Epidemiol       Date:  2018-03-23       Impact factor: 4.790
View more
  4 in total

Review 1.  Lactose: Characteristics, Food and Drug-Related Applications, and Its Possible Substitutions in Meeting the Needs of People with Lactose Intolerance.

Authors:  Simona Dominici; Francesca Marescotti; Chiara Sanmartin; Monica Macaluso; Isabella Taglieri; Francesca Venturi; Angela Zinnai; Maria Sole Facioni
Journal:  Foods       Date:  2022-05-19

2.  Experimental models of endocrine responsive breast cancer: strengths, limitations, and use.

Authors:  Robert Clarke; Brandon C Jones; Catherine M Sevigny; Leena A Hilakivi-Clarke; Surojeet Sengupta
Journal:  Cancer Drug Resist       Date:  2021-07-08

3.  Fetal therapies and trials for lysosomal storage diseases: a survey of attitudes of parents and patients.

Authors:  Marisa E Schwab; Julia E H Brown; Billie Lianoglou; Chengshi Jin; Patricia C Conroy; Renata C Gallagher; Paul Harmatz; Tippi C MacKenzie
Journal:  Orphanet J Rare Dis       Date:  2022-01-29       Impact factor: 4.123

Review 4.  Needs-driven talent and competency development for the next generation of regulatory scientists in Africa.

Authors:  Boitumelo Semete-Makokotlela; Gugu N Mahlangu; David Mukanga; Delese Mimi Darko; Peter Stonier; Luther Gwaza; Portia Nkambule; Precious Matsoso; Regine Lehnert; Bernd Rosenkranz; Goonaseelan Colin Pillai
Journal:  Br J Clin Pharmacol       Date:  2021-08-24       Impact factor: 3.716
  4 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.