New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has ...

Objective: To investigate the relative bioavailability and bioequivalence ... Therefore, the 20mg strength was chosen for this study. The study was conducted by the Human Pharmacology Unit ...

This method was applied to a pharmacokinetic analysis of phenobarbital in human plasma supporting a bioequivalence study of two pharmaceutical formulations. The test and reference formulations ...

Table III. Pharmacokinetic parameters for rebamipide following oral administration of granules or a tablet at a dose of 100mg in 27 healthy adult male volunteers [mean (SD)] ...

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New Delhi: BDR Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the bioequivalence (BE) study ...

Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed ...

Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that data from ...

Harmony Biosciences Holdings, Inc. today announced strong preliminary, unaudited net product revenues for Q4 and full year 2024 of $201 million and $714 million, respectively. Building on this ...

~ FDA Breakthrough Therapy designation received for PF614-MPAR ~ ~ PF614-MPAR second clinical trial initiated ~ ~ Lead clinical candidate identified for OUD program ~ ~ PF614 Phase 3 trial poised to ...

UCB, a global biopharmaceutical company, announced today that a single-injection 2 mL prefilled syringe and autoinjector, each containing 320 mg of BIMZELX® (bimekizumab-bkzx) is now available. These ...

FDA Breakthrough Therapy designation received for PF614-MPAR ~~ PF614-MPAR second clinical trial initiated ~~ Lead clinical candidate identified for OUD program ~~ PF614 Phase 3 trial poised to commen ...