Results 111 to 120 of about 16,124 (183)

Generic drug product development : bioequivalence issues /

, 2008
Includes bibliographical references and index.Bioequivalence using clinical endpoint studies / Christopher Hendy -- Evaluation of bioequivalence of highly variable drugs / Laszlo Endrenyi and Laszlo Tothfalusi -- Statistical considerations: alternate ...
Shargel, Leon(viaf)111014464, Kanfer, Isadore,   +1 more
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Pharmacokinetic and bioequivalence study of enteric-coated omeprazole capsule in healthy Chinese subjects under fasting and fed conditions. [PDF]

BMC Pharmacol Toxicol
Zhang F, Xie J, Li Y, Feng W, Su J, Mao N.   +5 more
europepmc   +1 more source

Pharmacokinetic and bioequivalence evaluation of two abiraterone acetate tablets under fasting conditions in healthy Chinese volunteers. [PDF]

Clinics (Sao Paulo)
Shi J, Zhu X, Zuo X, Kuang A, Wang Y, Liu C, Chen G, Zhang T.   +7 more
europepmc   +1 more source

Pharmacokinetics and safety comparison of cycloserine capsules and their generic counterpart: a randomized, open-label, two-period, two-sequence, single-dose crossover bioequivalence study in healthy Chinese subjects. [PDF]

Front Pharmacol
Peng X, Zhang L, Jia C, Ding C, Song H, Dong Z, Wu H, Bai W.   +7 more
europepmc   +1 more source

Virtual bioequivalence-guided PBBM prediction for ibuprofen/diphenhydramine citrate tablets: impact of dissolution variability and clinical standard development. [PDF]

Saudi Pharm J
Wang Z, Cao Z, Guo C, Zhang Q, Zhou R, Chen J, Su F, Liu W, Chu Z, Zheng L, Hu W.   +10 more
europepmc   +1 more source

A PBPK-VBE approach for bioequivalence extrapolation of senaparib capsule strengths in the context of nonlinear pharmacokinetics: bridging from the clinical starting dose to the linear pharmacokinetic range. [PDF]

Front Pharmacol
Wu X, Wang Z, He Y, Wu K, Liu B, Ma N, Cai S, Xu C, Xu Y, Zhao S, Wang H.   +10 more
europepmc   +1 more source

J Bioequivalence Bioavailab [PDF]

Drug development is an expensive process that is marked by a high-failure rate. For this reason early stage bioequivalence and pharmacokinetic studies are essential in determining the fate of new drug products.

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Intra-Subject Variability in Pharmacokinetics and Pharmacodynamics of Basal Insulin at Two Single-Dose Levels: Findings from Euglycemic Glucose Clamp Bioequivalence Studies of Insulin Degludec. [PDF]

Pharmaceutics
Liu H, Li T, Chen X, Yu H, Men Y, Tan H, Li J, Yu Y.   +7 more
europepmc   +1 more source

Pharmacokinetics and Bioequivalence of Apremilast Tablets in Chinese Healthy Subjects Under Fasting and Postprandial States [PDF]

Wanjun Bai,1 Xue Sun,1 Bo Qiu,1 Caihui Guo,1 Haojing Song,1 Yiting Hu,1 Xueyuan Zhang,2 Peihua Yin,3 Xiaoru Wang,3 Zhanjun Dong1 1Department of Pharmacy, Hebei General Hospital, Hebei Key Laboratory of Clinical Pharmacy, Shijiazhuang, Hebei, People’s ...
Hu Y, Zhang X, Dong Z, Qiu B, Yin P, Guo C, Wang X, Sun X, Song H, Bai W   +9 more
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Methodological Considerations in the Bioequivalence Assessment of Recombinant Human Serum Albumin [Letter]. [PDF]

Drug Des Devel Ther
Chang P, Shen D.
europepmc   +1 more source