Codon

JANUARY 21, 2024

With hepatitis C, what changed within the last 10 years was the development of direct-acting antivirals , or DAAs, which are packaged into pills that you can take once a day for a few months. There have been deaths in phase 1 medical and drug research among healthy participants. AP: Human challenge trials supported the F.D.A.

Vaccine 111

Vaccine Trials Disease Virus 111

Drug Discovery World

MARCH 13, 2023

Before 2019, CGT drug developers still had a young, academic mindset, ordering reagents, materials, and equipment haphazardly and assuming they would show up when needed. So, what are the most promising tactics for increasing public access to CGTs?  Reducing manufacturing costs may help significantly in bringing drug costs down.

Therapies 130

Therapies Drug Development Clinical Trials Cell Based Assays 130

Agency IQ

NOVEMBER 27, 2023

By early 2019, it became apparent that NDMA was not the only nitrosamine forming in API synthesis. EMA’s investigation ended up revealing even more causes of nitrosamine impurities in drugs, discovering, for example , that formation happened during the heat-sealing process of in certain products using blister-packaging.

Regulations 40

Regulations Production FDA Packaging 40

Drug Discovery World

FEBRUARY 6, 2023

Johannes Goll, Global Head of Emmes’ Biomedical Data Science and Bioinformatics department, explains how big data analytics can deliver improved therapies and bring clinical research one step close to realising the potential of personalised care. 2019 Nov 10;60(13):3161-71. Leukemia & Lymphoma.

Bioinformatics 130

Bioinformatics RNA Vaccine Clinical Trials 130

Agency IQ

AUGUST 11, 2023

By early 2019, it became apparent that NDMA was not the only nitrosamine forming in API synthesis. drug supply, manufacturers should conclude a risk assessment of approved or marketed products within 6 months of publication of this guidance,” FDA added, with confirmatory testing intended to be concluded within 3 years.

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FDA Science Production Regulations 40