Pharmaceutical Technology

DECEMBER 9, 2022

Dedicated experts in extractables and leachables and genotoxic impurities (GTIs) deploy organic trace analysis by liquid chromatography-mass spectrometry (LC-MS), as well as gas chromatography-mass spectrometry (GC-MS) equipment. However, messenger RNA (mRNA) based vaccines present particular analytical challenges.

Development 130

Development Manufacturing Production Vaccination 130

The Pharma Data

MARCH 8, 2021

The totality of the data from these studies indicates that molnupiravir is not mutagenic or genotoxic in in vivo mammalian systems. “We Animals were administered molnupiravir for longer and at higher doses (mg/Kg) than those employed in human studies.

Trials 69

Trials In-Vivo Genotoxicity RNA 69

Drug Discovery World

MAY 10, 2023

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issues guidelines and develops testing strategies for evaluating carcinogenicity along with other risks such as genotoxicity, immunotoxicity, and reproductive toxicity.

Bioassay 52

Bioassay Genotoxicity Drugs In-Vivo 52