Pharmaceutical Technology

JULY 25, 2022

You need good production, good science and engineering, and you need good lawyers. Drugs with an AB rating meet the required bioequivalence. More recently, Teva tried to reclassify the drug as a biologic as a move against generics producers, but a Washington, DC federal court issued a decision against that attempt.

Drugs 298

Drugs Manufacturing Production Marketing 298

Pharmaceutical Technology

JANUARY 6, 2023

It requires having access to proper techniques and skill sets, state-of-the-art equipment, process scientists and engineers who have a deep understanding of Quality by Design (QbD) principles, and methods for product and process characterisation. In vitro release testing to demonstrate bioequivalence.

Production 130

Production Manufacturing Development Bioequivalency 130

Drug Patent Watch

DECEMBER 10, 2024

These agencies set guidelines and regulations that generic drug manufacturers must follow to ensure that their products are bioequivalent to the innovator drug. One of the main challenges is ensuring bioequivalence with the innovator drug. ” National Academies of Sciences, Engineering, and Medicine , 2020.

Generic Drugs 52

Generic Drugs Development Bioequivalency Drugs 52

The Pharma Data

DECEMBER 27, 2020

platform and its large-capacity VV Cop TK”RR” oncolytic virus, engineered to encode both a Treg-depleting human recombinant anti-CTLA4 antibody generated by BioInvent’s n-CoDeR/F.I.R.S.T. Transgene and BioInvent International received regulatory approval in Belgium for a Phase I/IIa trial of oncolytic Vaccinia virus BT-001.

Trials 52

Trials Antibody Gene Therapy Gene 52

The Pharma Data

MAY 3, 2021

AstraZeneca has drawn criticism for saying it can’t share its vaccine tech with the WHO because it has no engineers available ‘to brief people and train them’ ( BI ). Korea To Toughen Co-Bioequivalence Study System Amid Generic Quality Issue ( Pink Sheet ). Coronavirus Pandemic.

Gene Therapy 52

Gene Therapy Vaccine Vaccination Bioequivalency 52