Adaptive clinical endpoint bioequivalence studies with sample size re-estimation based on a nuisance parameter.

Zhu, Lin; Sun, Wanjie

Zhu, Lin; Sun, Wanjie.

Affiliation

Zhu L; Louisiana State University Health Sciences Center , New Orleans , LA , USA.
Sun W; OB/DBVIII, FDA/CDER , Silver Spring , MD , USA.

J Biopharm Stat ; 29(5): 776-799, 2019.

Article in En | MEDLINE | ID: mdl-31505986

Subject(s)

Drugs, Generic/pharmacokinetics; Endpoint Determination/statistics & numerical data; Randomized Controlled Trials as Topic/statistics & numerical data; Double-Blind Method; Drugs, Generic/therapeutic use; Endpoint Determination/methods; Humans; Randomized Controlled Trials as Topic/methods; Sample Size; Therapeutic Equivalency

Key words

Adaptive design; bioequivalence; nuisance parameter; sample size re-estimation

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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Randomized Controlled Trials as Topic / Drugs, Generic / Endpoint Determination Type of study: Clinical_trials Limits: Humans Language: En Journal: J Biopharm Stat Journal subject: FARMACOLOGIA Year: 2019 Document type: Article Affiliation country: United States Country of publication: United kingdom

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