title: Requirements for anti-tuberculosis drug tender requests.
abstract: As more and more institutions and experts push for the use of fixed-dose combinations (FDC) of anti-tuberculosis drugs, the market will most probably change dramatically in the next few years. Prices should go down, but quality must remain an essential goal for managers in charge of the procurement process. General essential requirements for suppliers submitting for competitive bidding are reviewed, and in particular the WHO certification scheme. Even though the scheme does not dispense with the need to submit drugs to the quality control procedures required in the importing country, it is a very useful tool which should be encouraged in the supply process. Specific requirements for FDCs are discussed, particularly interpretation of the bioavailability tests which are compulsory for rifampicin-containing FDCs.
authors.affiliation: IUATLD, Paris, France. ATrebucq@compuserve.com
authors.forename: A
authors.initials: A
authors.lastname: Trébucq
authors.forename: J M
authors.initials: JM
authors.lastname: Caudron
authors.forename: J
authors.initials: J
authors.lastname: Pinel
mesh_terms: D000328:Adult; D000995:Antitubercular Agents / Q000008:administration & dosage / Q000191:economics* / Q000592:standards*; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D002648:Child; D003164:Competitive Bidding; D004338:Drug Combinations; D004345:Drug Industry / Q000191:economics / Q000592:standards*; D004335:Drug and Narcotic Control; D006801:Humans; D009313:National Health Programs / Q000592:standards; D011786:Quality Control; D014376:Tuberculosis / Q000188:drug therapy* / Q000517:prevention & control; D014944:World Health Organization
chemical_list: D000995:Antitubercular Agents; D004338:Drug Combinations