Remove Contamination Remove Generic Drugs Remove Protein Remove Regulation
article thumbnail

Quality by design with a focus on biosimilars

Pharmaceutical Technology

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.

article thumbnail

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

In February 2021, Pfizer and BioNTech announced results from an in vitro study published in NEJM that demonstrated sera from individuals immunized with BNT162b2 neutralize SARS-CoV-2 with the South African variant spike protein. The study investigated the full set of South African variant (also known as B.1.351

article thumbnail

COVID-19 Pandemic Coverage

XTalks

The company’s candidate vaccine, mRNA-1273, is a synthetic messenger RNA that encodes the stabilized SARS-CoV-2 spike protein. The University of Oxford/AstraZeneca partnership, in turn, is testing a viral-vectored coronavirus vaccine that again expresses the spike protein of SARS-CoV-2 virus.