Chiral bioanalytical methods in bioequivalence studies of intravenous vs. oral formulations of ibuprofen.
Sign Up to like & getrecommendations! Published in 2020 at "Chirality"
DOI: 10.1002/chir.23258
Abstract: According to the Ibuprofen Product-Specific Bioequivalence Guidance of the European Medicines Agency, achiral bioanalytical methods are considered acceptable for demonstration of bioequivalence of ibuprofen-containing products. The aim of this investigation is to compare the bioequivalence… read more here.
Keywords: bioequivalence; sum enantiomers; ibuprofen; bioanalytical methods ... See more keywords
Effect of Different Sampling Schedules on Results of Bioavailability and Bioequivalence Studies: Evaluation by Means of Monte Carlo Simulations.
Sign Up to like & getrecommendations! Published in 2017 at "Drug research"
DOI: 10.1055/s-0043-105797
Abstract: Bioavailability and bioequivalence study is one of the most frequently performed investigations in clinical trials. Bioequivalence testing is based on the assumption that 2 drug products will be therapeutically equivalent when they are equivalent in… read more here.
Keywords: bioequivalence; bioavailability; monte carlo; bioequivalence studies ... See more keywords
Meeting Regulatory Requirements for Drugs with a Narrow Therapeutic Index: Bioequivalence Studies of Generic Once-Daily Tacrolimus
Sign Up to like & getrecommendations! Published in 2020 at "Drug, Healthcare and Patient Safety"
DOI: 10.2147/dhps.s256455
Abstract: Abstract Despite growing clinical confidence in generics and their potential to reduce long-term healthcare costs, the transplant community have had real concerns about the use of generic immunosuppressants. One such immunosuppressant is tacrolimus, a cornerstone… read more here.
Keywords: generic daily; therapeutic index; narrow therapeutic; tacrolimus ... See more keywords
Generative Neural Networks for Addressing the Bioequivalence of Highly Variable Drugs
Sign Up to like & getrecommendations! Published in 2025 at "Algorithms"
DOI: 10.3390/a18050266
Abstract: Bioequivalence assessment of highly variable drugs (HVDs) remains a significant challenge, as the application of scaled approaches requires replicate designs, complex statistical analyses, and varies between regulatory authorities (e.g., FDA and EMA). This study introduces… read more here.
Keywords: highly variable; generative neural; variable drugs; bioequivalence ... See more keywords
Alternative Analysis Approaches for the Assessment of Pilot Bioavailability/Bioequivalence Studies
Sign Up to like & getrecommendations! Published in 2023 at "Pharmaceutics"
DOI: 10.3390/pharmaceutics15051430
Abstract: Pilot bioavailability/bioequivalence (BA/BE) studies are usually conducted and analysed similarly to pivotal studies. Their analysis and interpretation of results usually rely on the application of the average bioequivalence approach. However, due to the small study… read more here.
Keywords: bioavailability bioequivalence; bioequivalence studies; pilot bioavailability; pilot ... See more keywords
Unveiling the Potential of Cmax f2 Factor Applied to Pilot Bioavailability/Bioequivalence Studies—A Case Study with Pazopanib Drug Products
Sign Up to like & getrecommendations! Published in 2024 at "Pharmaceutics"
DOI: 10.3390/pharmaceutics16121579
Abstract: Background: When companies are uncertain about the potential of a new formulation to be bioequivalent to a Reference product, it is common practice to carry out downsized pilot studies as a gatekeeping in vivo strategy… read more here.
Keywords: methodology; cmax factor; pilot; bioequivalence ... See more keywords
Estimation of the Effects of Food on the Pharmacokinetic Results in Bioequivalence Studies
Sign Up to like & getrecommendations! Published in 2019 at "Revista de Chimie"
DOI: 10.37358/rc.19.8.7432
Abstract: Paper presents the effect of food on the pharmacokinetics of omeprazole and on the extraction yield of its internal standard, lansoprazole. The experimental data were obtained over three bioequivalence studies performed by the authors. Statistical… read more here.
Keywords: effect; bioequivalence studies; effects food; food ... See more keywords