Worldwide Clinical Trials

MAY 30, 2024

Authors: Rich Worldwide Clinical Trials Exec. This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. Director, Therapeutic Area Medical Lead.

Gene 162

Gene Clinical Trials Clinical Trials Gene Therapy 162

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.

Bioequivalency 130

Bioequivalency Production Branding Contamination 130

The Pharma Data

FEBRUARY 1, 2021

The addition of the IM administration of Plegridy to Biogen’s MS portfolio offers another important option at a time when MS patients are being encouraged to discuss their MS treatment and considerations around COVID-19 vaccination with their physicians.1,2 MS, the coronavirus and vaccines – updated global advice. percent vs. 32.1

FDA Approval 40

FDA Approval Bioequivalency Clinical Trials Clinical Trials 40

The Pharma Data

AUGUST 9, 2021

Food and Drug Administration (FDA) approved SKYRIZI 150 mg in April based on data from three clinical trials showing the single-dose SKYRIZI 150 mg injection was bioequivalent, working the same as two injections of SKYRIZI 75 mg per dose with a consistent efficacy and safety profile. ” The U.S.

Bioequivalency 52

Bioequivalency Vaccination Vaccine Medicine 52

The Pharma Data

DECEMBER 27, 2020

Even with the holidays among us, there were a number of clinical trial announcements. Vir Biotechnology and GlaxoSmithKline dosed the first patient in a new sub-trial of a Phase III study of monoclonal antibody VIR-7831 for hospitalized adults with COVID-19. Here’s a look. COVID-19-Related.

Trials 52

Trials Antibody Gene Therapy Clinical Trials 52

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. MYTH: Clinical pharmacology studies of biosimilars aim to establish safety and effectiveness. What is a Biosimilar?

Production 78

Production Insulin Branding Generic Drugs 78