1-5 of 5 Search Results for

bioequivalence

Follow your search
Access your saved searches in your account

Would you like to receive an alert when new items match your search?
×Close Modal
Sort by
Journal Article
Journal of Health Politics, Policy and Law (1 June 2017) 42 (3): 485–512.
Published: 01 June 2017
... regulation bioequivalence Recent advances in global health literature illustrate what has become axiomatic in the international development community: ensuring access to medicine is key to battling epidemics, 1 securing economic development, 2 and, as a new stream in foreign policy scholarship...
Journal Article
Journal of Health Politics, Policy and Law (1 April 1979) 4 (2): 155–175.
Published: 01 April 1979
... bioavailabilityZ4 and bioeq~ivalency~~issue before congressional committees, Senator Edward M. Kennedy directed the Ofice of Technology Assessment (OTA) of Congress to explore the drug bioequivalence issue and report in July 1974. 160 Journal of Health Politics, Policy and Law The drug industry...
Journal Article
Journal of Health Politics, Policy and Law (1 August 2017) 42 (4): 607–644.
Published: 01 August 2017
... device regulation. With respect to devices, the term substantial equivalence is the term of art used for substitution with a previously approved and marketed product (a “predicate” or “reference” product), while for drugs, “bioequivalence” and “therapeutic equivalence” are used for substitution with a...
Journal Article
Journal of Health Politics, Policy and Law (1 June 2013) 38 (3): 573–597.
Published: 01 June 2013
... is not enough to guarantee comparable quality (Steele 1962; Walker 1971; US Congress 1960, 1961, 1967 – 1973, 1972, 1973 – 1974; Silverman and Lee 1974).1 Modern regulations now require bioequivalence with the refer­ ence brand-­name product as a prerequisite for marketing the generic drug...
Journal Article
Journal of Health Politics, Policy and Law (1 December 2009) 34 (6): 979–1010.
Published: 01 December 2009
... a regu- latory authority from affirming the safety of a bioequivalent generic by using the preclinical and clinical trials data submitted when a product was initially registered. Central to this approach is the idea that the initial sponsoring company paid for the trials and thus owns the...