Results 1 to 10 of about 32,756 (214)

Bioequivalence of ZUNVEYL a Galantamine Prodrug to Galantamine Hydrobromide Immediate‐Release Demonstrated Under Fed and Fasting Conditions [PDF]

Alzheimers Dement
Kay D, Grady K, Wahlert A.
europepmc   +2 more sources

Bioequivalence Study of Palbociclib Tablets in Healthy Volunteers. [PDF]

Drug Des Devel Ther
Hu Y, Zhao N, Song H, Zhang J, Bi L, Qiu B, Xu Y, Jia C, Bai W.   +8 more
europepmc   +3 more sources

Bioequivalence in adults does not mean bioequivalence in children [PDF]

, 2016
De Bruyne, Pauline, Dossche, Lien, Michelet, Robin, Van Bocxlaer, Jan, Vande Walle, Johan, Vermeulen, An   +5 more
core   +2 more sources

Bioequivalence data analysis [PDF]

Translational and Clinical Pharmacology, 2020
SAS® is commonly used for bioequivalence (BE) data analysis. R is a free and open software for general purpose data analysis, and is less frequently used than SAS® for BE data analysis. This tutorial explains how R can be used for BE data analysis to generate comparable results with SAS®.
Gowooni Park, Hyungsub Kim, Kyun-Seop Bae   +2 more
openaire   +2 more sources

Bioequivalence Study of Two Long-Acting Formulations of Oxytetracycline Following Intramuscular Administration in Bovines [PDF]

, 2016
The aim of this study was to evaluate the bioequivalence of two commercial long-acting formulations based on oxytetracycline (OTC) hydrochloride between the reference formulation (Terramycin LA, Pfizer) and a test formulation (Cyamicin LA, Fort Dodge ...
Fernandez Lastra, Cecilia, Lucas, Maria Florencia, Marchetti, Maria Laura, Mariño, Eduardo, Mestorino, Nora, Modamio, Pilar, Segarra, Ignacio, Zeinsteger, Pedro   +7 more
core   +4 more sources

New Bioequivalence Studies : Individual Bioequivalence and Population Bioequivalence

YAKUGAKU ZASSHI, 2000
The bioequivalence study which is currently conducted in different countries is the so-called average bioequivalence approach; this approach has been indicated to be insufficient for assessing switchability between two formulations (i.e., from the reference formulation to the test formulation).
K, Nakai, M, Fujita, H, Ogata
openaire   +3 more sources

Generic versus brand-name drugs used in cardiovascular diseases [PDF]

, 2016
This meta-analysis aimed to compare the efficacy and adverse events, either serious or mild/moderate, of all generic versus brand-name cardiovascular medicines.
Boccia, Stefania, D'Andrea, Elvira, Flacco Maria, Elena, Ioannidis John, Pa, Manzoli, Lamberto, Marzuillo, Carolina, Panic, Nikola, Ricciardi, Walter, Siliquini, Roberta, Villari, Paolo   +9 more
core   +1 more source

Pharmacokinetics and pharmacodynamics of tiotropium solution and tiotropium powder in chronic obstructive pulmonary disease [PDF]

, 2013
The aim of the study was to characterize pharmacokinetics of tiotropium solution 5 µg compared to powder 18 µg and assess dose-dependency of tiotropium solution pharmacodynamics in comparison to placebo.
Cornelissen, PJG, Derom, Eric, Disse, B, Hohlfeld, JM, Peterkin, V, Sharma, A, Towse, L, van Noord, JA   +7 more
core   +1 more source

Pharmacokinetics and safety of highly variable nitroglycerin lingual spray (NLS) versus US-licensed nitroglycerin lingual spray reference product (Nitrolingual^®): a randomized, four-cycle, four-sequence, partially replicated crossover Phase I bioequivalence clinical trial. [PDF]

Front Pharmacol
Fang Y, Qi L, Wang Y, Han C, Zhang Q, Liu X, Liu J, Cheng X, Li Y, Li Y, Sun M, Liu L, Li P, Zhang Y, Liu H, Wang X.   +15 more
europepmc   +3 more sources

Taking Biologics for Granted? Takings, Trade Secrets, and Off-Patent Biological Products [PDF]

, 2005
Biologics are complex medicines which are often genetically engineered, and which are sure to play an important role in curing some of humankind\u27s worst diseases. Not surprisingly, generic companies want a part of the biologic market. The FDA believes
Wasson, Andrew
core   +3 more sources