Introduction: The immediate-release solid oral products containing very soluble and permeable drugs are candidates for the biowaiver process. This work aims to compare in vitro, silico, vivo data establish if previously published prednisone tablet formulations candidates.
 Method: To achieve this goal, permeation studies were conducted on Caco-2 cells. A previous bioequivalence study betwe...

When the patent of an innovative (brand-name) small-molecule drug expires, generic copies of the innovative drug may be marketed if their therapeutic equivalence to the innovative drug has been shown. The small-molecule drugs are considered therapeutically equivalent and can be used interchangeably if two drugs are shown to be pharmaceutically equivalent with identical active substance and bioe...

Generic drug are identical or bioequivalent to a branded drug in dosage form, safety, strength, route of administration, quality and performance characteristic and intended use. The advantage of generic drug is the low cost because they do not undergo any large expensive clinical trials like other formulations. In 2002 FDA,stated that the Americans saved 56.7 billion dollars and could save addi...

The objective of this study was to assess the bioequivalence between the omeprazole laboratory based formulation and the commercial formulation, Zimor Rubio, Spain, considered as reference formulation. The experiment was carried out according to a 2-period, 2-sequence crossover design with a two week washout period. A validated high performance liquid chromatographic method was applied for in v...

OBJECTIVE To evaluate the bioavailability of vitamin D in capsules as compared with oily drops in nuns living in a closed community with very low sun exposure. METHODS A randomized, 2 x 2 crossover, open clinical trial was conducted, with 18 nuns aged between 20 and 75 years. Samples were collected in the fasting state and at 4, 8, 12 and 24 hours following the administration of capsules and ...

Concerns have been raised regarding the postmarketing quality of generic drugs. This study assessed the pharmacokinetic and pharmacodynamic equivalence of generic and brand atenolol tablets in 24 healthy male volunteers in a single-dose, open, randomized, two-period crossover study under fasting conditions. Blood samples were collected for 24 h post dosing and assayed for atenolol using HPLC. B...

A two-period, randomized, complete crossover study was performed to evaluate the pharmacokinetic profiles of Testim (AA2500), a new 1% testosterone topical gel formulation, compared to AndroGel, an already available 1% testosterone topical gel. Twenty-nine hypogonadal subjects received a single dose (50 mg testosterone) of each formulation seven days apart. C(max) estimates for total testostero...

Fosaprepitant is an intravenous formulation of aprepitant, an oral NK1 antagonist used to prevent chemotherapy-induced nausea and vomiting. This randomized study was designed to evaluate fosaprepitant in polysorbate 80 vehicle for tolerability and bioequivalency to aprepitant. Tolerability was assessed by physical and laboratory examinations and adverse events. Plasma collected for 72 hours was...