XTalks

NOVEMBER 6, 2024

Gelteq’s formulations enable the delivery of various active ingredients like branched-chain amino acids, protein, caffeine and essential minerals, opening applications in sports performance, nutrition and therapeutic use.

Drug Delivery 81

Drug Delivery Drugs Bioequivalency Bioavailability 81

Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug. For biosimilars, however, this process is slightly more complex.

Bioequivalency 130

Bioequivalency Production Contamination Branding 130

XTalks

FEBRUARY 8, 2021

They include proteins, monoclonal antibodies and vaccines that are considered to be “ highly similar ” to biological products that have already been approved by the FDA. Unlike small-molecule generic drugs, biosimilars do not need to demonstrate bioequivalence to the innovator product. What is a Biosimilar?

Production 55

Production Insulin Branding Generic Drugs 55

Worldwide Clinical Trials

MAY 30, 2024

Approval has been based on bioequivalence with the FDA stating that the effectiveness of Radicava ORS is based on a study showing comparable levels of Radicava ORS in the bloodstream to the levels from the IV formulation of Radicava. This is administered according to the same treatment regimen as for the IV infusion.

Gene 204

Gene Clinical Trials Clinical Trials Gene Therapy 204

The Pharma Data

DECEMBER 27, 2020

CureVac and the University Medical Center of Mainz launched a Phase III trial of CVnCoV, their COVID-19 vaccine candidate, in healthcare workers. The study will evaluate the safety and immunogenicity of the vaccine in a two-dose schedule of 12 micrograms. AZR-MD-001’s active ingredient is selenium disulfide.

Trials 52

Trials Antibody Gene Therapy Gene 52