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

Pharmacy Checkers

DECEMBER 12, 2019

The FDA’s continuing problems with inspections of drug manufacturing plants, as well as the relative comparative strength of other drug regulators, ought to inspire serious reflection, even introspection, among drug safety policy professionals about whether or not, and how, we have the gold standard.

Drugs 71

Drugs Manufacturing Medicine Compliance 71

XTalks

SEPTEMBER 14, 2020

By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. Sinovac Biotech is already in Phase III clinical trials testing its CoronaVac vaccine which it plans to evaluate in approximately 11,000 volunteers. The price of that prize is incalculable.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92

The Pharma Data

MAY 4, 2021

On December 21, 2020, which falls in Pfizer’s international first-quarter 2021, Pfizer and Viatris completed the termination of a pre-existing strategic collaboration between Pfizer and Mylan for generic drugs in Japan (Mylan-Japan collaboration) and Pfizer transferred related operations that were part of the Mylan-Japan collaboration to Viatris.

Vaccination 40

Vaccination Vaccine Production Sales 40