|NOUN || bioequivalence | bioequivalences |
NOUN article.ind sg | pl
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- January 4, 2016, the national bioequivalence center, the first in Algeria, was inaugurated by the Minister of Industry and Mines, Abdeslam Bouchouareb.
- This concept of bioequivalence is important because it is currently used as a yardstick in the authorization of generic drugs in many countries.
- The volume estimate of 250 ml is derived from typical bioequivalence study protocols that prescribe administration of a drug product to fasting human volunteers with a glass of water.
- Gilberto De Nucci founded the Cartesius Analytical Unit, a very important enterprise on the quality approval of new drugs as "generics" throughout bioequivalence essays.
- In 2017, The European Medicines Agency recommended suspension of a number of nationally approved medicines for which bioequivalence studies were conducted by Micro Therapeutic Research Labs in India, due to inspections identifying misrepresentation of study data and deficiencies in documentation and data handling.
- Head-to-head settings with OFM have proven particularly useful for the evaluation of topical generic products, which need to demonstrate bioequivalence to the reference listed drug product to obtain market approval.
- While the mechanisms by which a formulation affects bioavailability and bioequivalence have been extensively studied in drugs, formulation factors that influence bioavailability and bioequivalence in nutritional supplements are largely unknown.
- The foundation is made up of five healthcare facilities, one university campus with a training capacity in the form of three faculties and two institutes of higher education, three research centers, one center of bioequivalence studies, and several mobile care units.
- Unlike generics, biosimilars cannot be approved on the basis of minimal and inexpensive tests to prove bioequivalence.
- Benet regularly advised the FDA in proposing guidance in the field of bioequivalence.
- Extreme bioavailability differences of up to 4-fold have been reported comparing effervescent tablets with ordinary tablets, highlighting the need for extra bioequivalence studies when switching dosage forms.
- In the presence of such CPP, WHO recommends to national authorities to ensure that analytical methods can be confirmed by the national laboratory, to review and if necessary to adapt product information as per local labelling requirements, and to assess bioequivalence and stability data if necessary.
- Terapia S.A. has been the first Romanian company to have a bioequivalence laboratory accredited by GCP.
- The Cmax is often measured in an effort to show bioequivalence (BE) between a generic and innovator drug product.
- Cmin is also an important parameter in bioavailability and bioequivalence studies, it is part of the pharmacokinetic information recommended for submission of investigational new drug applications.
- In 1945–2017, bioequivalence studies were only required for generics of drugs that are less than four years old.
- The Act facilitates the filing of ANDAs by generic companies by preventing the FDA from asking a generic company to provide anything other than information on how it is going to manufacture the drug, quality assurance, and a study showing that the drug acts the same in a human as the innovator drug; this is called bioequivalence.
- Many scientific endeavors are dependent upon accurate quantification of drugs and endogenous substances in biological samples; the focus of bioanalysis in the pharmaceutical industry is to provide a quantitative measure of the active drug and/or its metabolite(s) for the purpose of pharmacokinetics, toxicokinetics, bioequivalence and exposure–response (pharmacokinetics/pharmacodynamics studies).
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