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References in periodicals archive ?
He stated that the two-day symposium would provide an in-depth understanding of the theory; practices and critical issues related to bioequivalence assessment of investigational drugs.
The single center bioequivalence study was conducted on 52 subjects.
The bioequivalence problem was confirmed in an FDA-sponsored study conducted in 2010, comparing the bioequivalence of the Impax/Teva product to Wellbutrin XL 300 mg in 24 healthy adults, which determined that the generic tablets "fail to release bupropion into the blood at the same rate and to the same extent as Wellbutrin XL 300 mg," according to the statement.
The FALCON II enables drug manufacturers to perform chemical imaging of particles in droplets to distinguish the identity, particle size distribution of drug and other substances, aggregation, and the correlation about the location of the material in the formulation something drug makers have been unable to achieve in the past with standard optical microscopy as part of bioequivalence testing.
The majority of the time and money for generic drug companies to achieve bioequivalence is involved in product development and clinical trials.
Establishing bioequivalence for our new disodium salt formulation is the last remaining step in this reformulation process, following which we eagerly anticipate moving ahead in our clinical evaluation of CH-1504 as a safe and effective treatment alternative to methotrexate in our planned Phase II trial in the fourth quarter," commented Dr.
Rheological measurements are a method of determining bioequivalence in topical creams used for dermatological products.
The Food and Drug Administration allows generic medications to have a bioequivalence ranging between 80% and 125% of the brand name medication.
Editorial includes information about generics, patient FAQs, bioequivalence, product focus and product news.
Food & Drug Administration (FDA) which indicates that the FDA has made a preliminary review of the study results and POZEN's summary analyses of a Phase 1 study (115 Study) to assess the bioequivalence of PA32540 to enteric-coated (EC) aspirin 325 mg using acetylsalicylic acid (ASA) as the analyte.
June 25, 2015 /PRNewswire/ -- Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative pain treatments, today announced top-line results from a pivotal pharmacokinetic study (067-EG-011) demonstrating bioequivalence of Egalet-001 60 mg to MS Contin 60 mg.
KARACHI -- The Centre for Bioequivalence Studies and Clinical Research (CBSCR), University of Karachi, is offering for the first time in Pakistan a unique facility of "certified reference laboratory" that would conduct bioequivalence evaluation and development of generic pharmaceutical products in full compliance with the regulatory authorities in Europe, USA and Japan.