#PAGE_PARAMS# #ADS_HEAD_SCRIPTS# #MICRODATA#

Registering New Drugs for Low-Income Countries: The African
Challenge


article has not abstract


Vyšlo v časopise: Registering New Drugs for Low-Income Countries: The African Challenge. PLoS Med 8(2): e32767. doi:10.1371/journal.pmed.1000411
Kategorie: Policy Forum
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pmed.1000411

Souhrn

article has not abstract


Zdroje

1. Belgharbi

L

2007

Vaccine regulatory issues in African countries: building

& sustaining national capacity. EDCTP consultative meeting; 11 June

2007; Geneva, Switzerland.

Available: http://www.edctp.org/fileadmin/documents/Regulatory_meeting_Lahouari_Belgharbi.pdf.

Accessed 4 January 2011

2. World Health Organization

2006

Comite Regional de l'Afrique. Cinquante-sixieme session,

Addis-Abeba, Ethiopie, 2 aout-1er septembre 2006. Autorites de

reglementation pharmaceutique: situation actuelle et perspectives: Report du

Directeur regional.

Available: http://afrolib.afro.who.int/RC/RC%2056/Doc_Fr/AFR%20RC56%2011%20AUTORITES%20%20REGLEMENT%20PHARMACEUTIQUE.pdf.

Accessed 23 September 2010

3. World Health Organization

2010

Regulatory harmonization: updating medicines regulatory systems

in sub-Saharan African countries.

WHO Drug Information

24

1

6

20

Available: http://whqlibdoc.who.int/druginfo/24_1_2010.pdf. Accessed 4

January 2011

4. Moran

M

Guzman

J

McDonald

A

Wu

L

Omune

B

2010

Registering new drugs: the African context. London: Health Policy

Division, The George Institute for International Health.

Available: http://www.dndi.org/images/stories/advocacy/regulatory-report_george-institute-dndi_jan2010.pdf.

Accessed 4 January 2011

5. US Food and Drug Administration

2010

Orange book: approved drug products with therapeutic equivalence

evaluations.

Available: http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=021752&TABLE1=OB_Rx.

Accessed 4 January 2011

6. US Food and Drug Administration

2010

President's Emergency Plan for AIDS Relief: Approved and

tentatively approves antiretrovirals in association with the

President's Emergency Plan.

Available: http://www.fda.gov/internationalprograms/fdabeyondourbordersforeignoffices/asiaandafrica/ucm119231.htm.

Accessed 4 January 2011

7. Cipla

2007

Once-daily dosage lamivudine another ARV first for Cipla Medpro.

Available: http://www.ciplamedpro.co.za/news.php?nid=26. Accessed 4

January 2011

8. Act with ASMQ

2008

A worldwide public partnership makes available a new, once-a-day

fixed-dose combination against malaria.

Available: http://www.actwithasmq.org/index2.php?inter=0&&hight=0.

Accessed 4 January 2011

9. Act with ASAQ

2010

ASAQ: hope for malaria.

Available: http://www.actwithasaq.org/en/asaq1.htm. Accessed 4 January

2011

10. Nwaka

S

Ilunga

TB

Da Silva

JS

Rial Verde

E

Hackley

D

2010

Developing ANDI: a novel approach to health product R&D

in Africa.

PLoS Med

7

6

e1000293

doi:10.1371/journal.pmed.1000293.

11. Institute for One World Health

2010

Next steps.

Available: http://www.oneworldhealth.org/next_steps. Accessed 4 January

2011

12. Novartis

2008

Novartis receives FDA priority review for Coartem®,

potentially the first artemisinin-based combination treatment (ACT) for

malaria in the US [press release].

Basel

Novartis

Available: http://hugin.info/134323/R/1251164/271951.pdf. Accessed 6 January 2011

13. World Health Organization

2010

HA210 World Health Organization public assessment report.

Available: http://apps.who.int/prequal/WHOPAR/WHOPARPRODUCTS/TriomunePart7v10.pdf.

Accessed 4 January 2011

14. US Food and Drug Administration

2009

FDA Approves Coartem tablets to treat malaria.

Available: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm149559.htm.

Accessed 4 January 2011

15. World Health Organization

2010

WHO list of prequalified medicinal products.

Available: http://apps.who.int/prequal/. Accessed 4 January 2011

16. Institute for One World Health

2009

Visceral leishmaniasis.

Available: http://www.oneworldhealth.org/leishmaniasis. Accessed 4

January 2011

17. World Health Organization

2008

HA343 World Health Organization public assessment report.

Available: http://apps.who.int/prequal/WHOPAR/WHOPARPRODUCTS/HA343Part7v2.pdf.

Accessed 4 January 2011

18. European Medicines Agency

2005

Background information on the procedure.

Available: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Procedural_steps_taken_before_authorisation/human/000594/WC500043717.pdf.

Accessed 16 March 2010

19. Gilead

2010

Gilead international access operations.

Available: http://www.gilead.com/pdf/GAP_Registration_Status.pdf.

Accessed 4 January 2011

20. Medicines for Malaria Venture

2010

MMV Interactive Science Portfolio, Q4 2010. Geneva: Medicines for

Malaria Venture. Available: http://www.mmv.org/research-development/science-portfolio. Accessed 6

January 2011

21. Global Alliance for TB Drug Development

2011

TB Alliance portfolio March 2010. New York: Global Alliance for TB Drug

Development. http://www.tballiance.org/new/portfolio/html-portfolio.php. Accessed 6 January 2011

22. Wells T

2009

Building a robust portfolio of new medicines. Drug Discovery World.

Available: http://www.ddw-online.com/therapeutics/258406/building_a_robust_portfolio_of_new_medicines.html.

Accessed 6 January 2011

23. Drugs for Neglected Disease Initiative

2010

Fexinidazole (HAT). Available: http://www.dndi.org/portfolio/fexinidazole.html. Accessed 6 January 2011

Štítky
Interné lekárstvo

Článok vyšiel v časopise

PLOS Medicine


2011 Číslo 2
Najčítanejšie tento týždeň
Najčítanejšie v tomto čísle
Kurzy

Zvýšte si kvalifikáciu online z pohodlia domova

Získaná hemofilie - Povědomí o nemoci a její diagnostika
nový kurz

Eozinofilní granulomatóza s polyangiitidou
Autori: doc. MUDr. Martina Doubková, Ph.D.

Všetky kurzy
Prihlásenie
Zabudnuté heslo

Zadajte e-mailovú adresu, s ktorou ste vytvárali účet. Budú Vám na ňu zasielané informácie k nastaveniu nového hesla.

Prihlásenie

Nemáte účet?  Registrujte sa

#ADS_BOTTOM_SCRIPTS#