Linked Life Data

15027065

Source:http://linkedlifedata.com/resource/pubmed/id/15027065

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:dateCreated
2004-3-17
pubmed:abstractText
The majority of pharmaceutical products are patented in early phases of their discovery to preclude competition by similar products. Due to unusual circumstances (botulinum toxin is an unpatentable natural product and it is considered to be a biological weapon), technology know-how for botulinum toxin production was classified rather then available in the scientific community. Botulinum toxin type A was marketed in two pharmaceutical distinct formulations from competitor companies. Serendipity proved that the two formulations were not equipotent in terms of mouse units. From a regulatory point of view, differences in potency of distinct formulations are not a matter of concern because each formulation is licensed based on its own set of data. As far as the data in each case is sufficient to prove that a particular formulation is safe and efficacious at its defined dosage, a license for use can be granted. On the other hand, generation of data on comparability is the only way that clinicians and managers can ascertain which product (formulation, serotype) is most cost-effectiveness and to determine whether there are relevant differences in their safety profiles. The results of the systematic review of head-to-head randomised trials comparing BOTOX to Dysport suggest that the two formulations are not bioequivalent whatever the dose relationship. Data on comparative immunogenicity are not available. The indirect comparison of the results obtained in randomised clinical trials comparing BOTOX to placebo and Dysport to placebo support that intrinsic differences are present in the two products. It is concluded that comparative economic evaluations of different botulinum toxin formulations should move away from cost-minimization approaches based on the presumption of bioequivalence and move toward cost-effectiveness or cost-utility models.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Mar
pubmed:issn
0885-3185
pubmed:author
pubmed:copyrightInfo
Copyright 2004 Movement Disorder Society
pubmed:issnType
Print
pubmed:volume
19 Suppl 8
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
S129-36
pubmed:dateRevised
2010-11-18
pubmed:meshHeading
pubmed:year
2004
pubmed:articleTitle
Clinical comparability of marketed formulations of botulinum toxin.
pubmed:affiliation
Laboratory of Clinical Pharmacology and Therapeutics, Lisbon School of Medicine, Lisbon, Portugal. crissampaio@mail.telepac.pt
pubmed:publicationType
Journal Article, Comparative Study, Review