Equivalence of Generic Glatiramer Acetate in Multiple Sclerosis: A Randomized Clinical Trial.

Importance: The patents for the first approved treatments for relapsing-remitting multiple sclerosis are expiring, creating the opportunity to develop generic alternatives.

Objective: To evaluate in the Glatiramer Acetate Clinical Trial to Assess Equivalence With Copaxone (GATE) study whether generic glatiramer acetate (hereafter generic drug) is equivalent to the originator brand glatiramer acetate (hereafter brand drug) product, as measured by imaging and clinical end points, safety, and tolerability.

Design, Setting, And Participants: Randomized, multicenter, double-blind, active and placebo-controlled phase 3 trial.

A phase I dose-escalation and bioequivalence study of a trastuzumab biosimilar in healthy male volunteers.

Background: Trastuzumab (Herceptin(®)) is a humanized monoclonal antibody targeting the human epidermal growth factor receptor 2 (HER2) and is used in the treatment of HER2-overexpressing breast and gastric cancer. FTMB is being developed as a biosimilar of trastuzumab.

Objective: In this combined dose-escalation and bioequivalence study of parallel design, the pharmacokinetic profile of FTMB was compared with Herceptin(®).

Induction of spermatogenesis by recombinant follicle-stimulating hormone (puregon) in hypogonadotropic azoospermic men who failed to respond to human chorionic gonadotropin alone.

A multicenter, open-label, randomized efficacy and safety study was performed with combined human chorionic gonadotropin (hCG) and recombinant follicle-stimulating hormone (recFSH) (Puregon(R)) treatment to induce spermatogenesis in hypogonadotropic hypogonadal male patients. Patients were pretreated for 16 weeks with hCG to normalize testosterone levels. A total of 30 of 49 (61%) subjects had normalized testosterone levels but were still azoospermic after the hCG-alone phase.

Assessment of intestinal permeability: enzymatic determination of urinary mannitol, raffinose, sucrose and lactose on Hitachi analyzer.

The sugar absorption test is the usual test for measurement of intestinal permeability. After intestinal absorption of probe sugars the subsequently excreted sugars are measured in urine. We have developed four enzymatic methods for the measurement of the urinary concentration of the probe sugars mannitol, raffinose, lactose and sucrose.

Quantitative determination of faecal fatty acids and triglycerides by Fourier transform infrared analysis with a sodium chloride transmission flow cell.

We studied the applicability of Fourier transform infrared (FTIR) spectroscopy to determine the amount of faecal fatty acids and triglycerides in faeces. For this, we have optimised a simple hexane extraction procedure of stool. After extraction, an aliquot of the hexane layer is directly injected into the measurement cell of the spectrophotometer and absorbance at 1714 cm(-1) and 1751 cm(-1) is read for quantitation of fatty acids and triglycerides, respectively.

Single dose pharmacokinetics and effects on follicular growth and serum hormones of a long-acting recombinant FSH preparation (FSH-CTP) in healthy pituitary-suppressed females.

Background: A long-acting FSH preparation has been developed by site-directed mutagenesis and gene transfer techniques.

Methods: In this open-label trial, we investigated the pharmacokinetic and pharmacodynamic properties of FSH-CTP (corifollitropin alpha, Org 36286) in healthy female volunteers. Twenty-four subjects were treated with a high-dose oral contraceptive (OC) to suppress pituitary function.