Non-inferiority versus equivalence clinical trials in assessing biological products

Pinto, Valdair Ferreira

doi:10.1590/s1516-31802011000300011

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“…Any improvement seen with the new treatment still lies within the definition of noninferiority;78 therefore, the conclusion of noninferiority does not rule out possible superiority of the new treatment 79…”

Section: Clinical Use and Efficacy Safety And Tolerability Of Incobmentioning

confidence: 99%

Differential characteristics of incobotulinumtoxinA and its use in the management of glabellar frown lines

Prager

2013

CPAA

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ObjectivesThis review examines the pharmacologic and clinical characteristics of incobotulinumtoxinA (Xeomin®/Xeomeen®/Bocouture®/XEOMIN Cosmetic™; botulinum toxin type A [150 kDa]), which is free from complexing proteins, and discusses its efficacy and safety in the treatment of glabellar frown lines. Differences between incobotulinumtoxinA and other commercially available botulinum neurotoxin type A (BoNT/A) products that have been approved by the European Medicines Agency, US Food and Drug Administration, and other regulatory agencies for this indication are also discussed.FindingsIncobotulinumtoxinA differs from other commercially available BoNT/A preparations, in that it is free from complexing proteins and contains only active neurotoxin, minimizing foreign protein load. IncobotulinumtoxinA is commonly used at a 1:1 dose ratio with onabotulinumtoxinA and displays comparable efficacy and safety; furthermore, it is associated with early onset and long duration of effect, and high levels of subject satisfaction. In terms of practical considerations, incobotulinumtoxinA does not require cold storage and demonstrates low spread, enabling precise treatment and good tolerability.ConclusionIncobotulinumtoxinA is an efficacious and well-tolerated treatment for glabellar frown lines. It differs from other BoNT/A preparations, in that it is free from complexing proteins and contains only active neurotoxin, which is relevant clinically, as this reduces the foreign protein load and minimizes the risk of neutralizing antibody production. In practical terms, incobotulinumtoxinA has a long shelf-life, remaining stable without the need for refrigeration, and due to its limited spread is a precise localized treatment.

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Section: Clinical Use and Efficacy Safety And Tolerability Of Incobmentioning

confidence: 99%

Differential characteristics of incobotulinumtoxinA and its use in the management of glabellar frown lines

Prager

2013

CPAA

View full text Add to dashboard Cite

show abstract

Non-inferiority versus equivalence clinical trials in assessing biological products

Abstract: Letter to editor Non-inferiority versus equivalence clinical trials in assessing biological products Estudos de clínicos de não inferioridade versus equivalência na avaliação de produtos biológicos

Cited by 1 publication

References 1 publication

Differential characteristics of incobotulinumtoxinA and its use in the management of glabellar frown lines

Differential characteristics of incobotulinumtoxinA and its use in the management of glabellar frown lines

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