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References in periodicals archive ?
As per the agreement, the private company intends to submit bioequivalence studies and clinical trials projects regulatory (local and international) for seeking marketing authorization.
Except for types of drugs exempt from bioequivalence study, and some particular cases for which pharmaceutical equivalence tests may replace in vivo bioequivalence assays, the demonstration that a generic drug is in fact interchangeable with the corresponding reference drug product requires a clinical bioequivalence study (9).
the probability of claiming bioequivalence based on the proposed method given that T and R are claimed to be bioequivalent based on the traditional one-parameter approach) will be evaluated.
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.
The present study was undertaken to perform comparative analysis of bioequivalence of tablets and capsules of meloxicam, developed at the Tashkent Pharmaceutical Institute.
Copaxone, claims Peptimmune, is a "pro-drug" which makes the demonstration of bioequivalence difficult for a generic copy.
Table Bioequivalence among generic psychotropics: What to know before you switch Medication Comments Amitriptyline/perphenazine Generic formulations may not be interchangeable * Anticonvulsants Because these medications have a narrow therapeutic index when used for seizure disorders, patients are recommended to not switch formulations.
In their petition, Astellas requested that the FDA take additional measures to protect transplant patients from substitute critical dose immunosuppressant drugs that have not demonstrated bioequivalence in rigorous clinical trials in transplant recipients.
net), a leading Contract Research Organization (CRO) to further validate ChemImage's Raman Chemical Imaging for bioequivalence applications for nasal spray suspensions.
com), Pittsburgh, one of the world's leading chemical and biological imaging technology solutions companies, is set to help generic drug makers become the first to achieve bioequivalence for nasal spray suspensions and inhalation products by providing a faster and more accurate way to determine drug particle size distribution in a drug product.