Examples of 'bioequivalence studies' in a sentence
Meaning of "bioequivalence studies"
Clinical trials or studies conducted to compare the pharmacokinetic properties of two drug formulations, usually a generic version and a brand-name version, to determine if they are equivalent in terms of safety and efficacy
How to use "bioequivalence studies" in a sentence
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bioequivalence studies
Use of group sequential design in bioequivalence studies.
The bioequivalence studies are crucial in order.
Such studies usually involve bioequivalence studies.
Bioequivalence studies usually form the basis for approval of generic medicines.
Exemption from the requirement for bioequivalence studies.
The filing is based on bioequivalence studies which were completed earlier this year.
Clinical data requirements are mainly pharmacokinetic bioequivalence studies.
Results of the bioequivalence studies.
The comparison or reference product is established by the second person through its bioequivalence studies.
Waiver from bioequivalence studies.
Know when and how to perform bioavailability and bioequivalence studies.
Cases for which certain bioequivalence studies were not relevant.
The Applicant therefore only performed the required bioequivalence studies.
ADVINCIA carries out bioequivalence studies for local and international generic pharmaceutical companies.
Design and monitoring of bioequivalence studies.
See also
The bioequivalence studies confirmed that dose dumping did not occur with Didanosine and associated names.
Automate bioavailability and bioequivalence studies.
Good quality bioequivalence studies will help to ensure safety, efficacy, and potency of a generic drug.
A similar situation was observed in the segment of bioequivalence studies by foreign sponsors.
The conduct of bioequivalence studies for veterinary medicinal products Released for consultation January 2000.
Brief overview of sources of variability in bioequivalence studies 2.
In other words, data from bioequivalence studies should have a normal distribution.
The BCS-based biowaiver approach is meant to reduce in vivo bioequivalence studies.
A note on sample size determination for bioequivalence studies with higher-order crossover designs.
Bioequivalence can be determined by in vitro dissolution testing and / or in vivo bioequivalence studies.
Design, perform and interpret the bioequivalence studies in ensuring the effectiveness of the dosage forms.
The student must demonstrate knowledge of drug stability pharmacokinetic, bioavailability and bioequivalence studies.
Bioequivalence ( CS-BE ) for pivotal bioequivalence studies is to be included in this module.
In addition, the MAH provided supportive pharmacokinetic data in the form of two bioequivalence studies.
Souza, r . m . \ statistical modeling in bioequivalence studies under bayesian approach.
Conducted 17 bioequivalence studies for a total of 12 generic drugs under development.
Both pharmacokinetic studies as well as bioavailability / bioequivalence studies are kinetic models.
The methods are useful, inter alia, for quality control and / or bioequivalence studies of a-Gal A preparations.
Paula has directly supervised 40 Bioequivalence studies.
Top-16 medical organizations on the activity of participation in Bioequivalence Studies approvals issued in 2017.
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