Starting or Strengthening a Drug Bulletin - A Practical Manual
(2005; 165 pages) View the PDF document
Table of Contents
View the documentPreface
View the documentHow the manual was produced
View the documentAbout ISDB
View the documentExecutive summary
Open this folder and view contents1. Introduction
Open this folder and view contents2. Rational use of medicines
Open this folder and view contents3. What are drug bulletins?
Open this folder and view contents4. Defining aims, target and type of bulletin
Open this folder and view contents5. Planning resources
Open this folder and view contents6. Planning bulletin production: schedules and timing
Open this folder and view contents7. The editorial process
Open this folder and view contents8. Reviewing a new drug: is it a therapeutic advance?
Close this folderAnnexe to Chapter 8: Evaluating harm
View the document8.An-1 Talk about harm, not risk
View the document8.An-2 Assessment of causation of a harmful effect
Open this folder and view contents8.An-3 Assessing coherence with preclinical data
View the document8.An-4 References
Open this folder and view contents9. Design and production
Open this folder and view contents10. Dissemination
Open this folder and view contents11. Organizational and legal issues
Open this folder and view contents12. Evaluating quality and usefulness
Open this folder and view contents13. Partnership and collaboration
Open this folder and view contents14. Keeping records and creating a memory
Open this folder and view contentsAppendix: Electronic sources of information
 

8.An-4 References

1. Herxheimer A. Communicating with patients about harms and risks. PloS Medicine 2005; 2(2):e42-43. Available at: http://medicine.plosjournals.org/perlserv/?request=getdocument&doi=10.1371/journal.pmed.0020042

2. Fisher FD. An introduction to epidemiology - a programmed text. New York: Appleton-Century-Crofts; 1975.

3. Rothman KJ, Greenland S. Causation and causal inference. In: Rothman KJ, Greenland S, editors. Modern epidemiolog. 2nd ed. Philadelphia: Lippincott Williams & Wilkins; 1998.

4. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981 Aug;30(2):239-45.

5. Pioglitazone hydrochloride, new drug approval package (NAP). Japan Pharmacists Education Center 1999 (in Japanese). Available at: http://www.jpec.or.jp/

6. GlaxoSmithKline. Study reports of paroxetine for pediatric and adolescent patients. Unipolar major depression: study 329. Available at: http://www.gsk.com/media/paroxetine.htm

7. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidelines. Safety guidelines. Available at:
http://www.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254

8. ICH Safety guideline S1C: Dose selection for carcinogenicity studies of pharmaceuticals. Available at: http://ww.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254

9. Addendum to ICH S1C: (Addition of a limit dose and related notes). Available at:
http://www.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254

10. Kusuri-no-Check Editorial Team. Don't take ACTOS!!! Kusuri-no-Check (Check-up your Medicines) 2004;1:36-39 and 43-47. Available at:
http://www.npojip.org/english/check-up1/check-up04.htm

11. Hama R, Sakaguchi K. Gefitinib story. ISDB Newsletter 2003;17(1):6-9. Available at:
http://www.npojip.org/english/The-gefitinib-story.pdf

12. Hama R. Adrenal insufficiency induced by inhaled fluticasone propionate. The Informed Prescriber 2004;19:25-29. This summary will be available at the following site in a few months:
http://www.npojip.org/english/

13. Hama R, Shimazu T. Tacrolimus (Protopic) ointment and cancer risk. The Informed Prescriber 2003;8:86-90. Summary is available at:
http://www.fda.gov/ohrms/dockets/ac/05/slides/20054089OPH2_09_Rokuro%20Hama%20letter.pdf and http://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4089OPH2_10_Rokuro%20Hama%20slides_files/frame.htm

14. U.S. Food and Drug Administration Pediatric Advisory Committee 15 February 2005.
http://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4089s2.htm

15. CHMP to look at potential cancer risk with pimecrolimus and tacrolimus. SCRIP No.3053, 11 May 2005: 30.

 

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