Vial

MAY 20, 2024

Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. The two broadest categories of drug development can be separated into the preclinical and clinical research stages. What is a Pre-Clinical CRO?

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Clinical Research Clinical Trials Research Trials 52

The Pharma Data

JANUARY 11, 2021

CAMBRIDGE, England–( BUSINESS WIRE )– CN Bio , a leading developer of single and multi organ-on-chip microphysiological systems (MPS) that improve the accuracy and efficiency of drug discovery, today announced the publication of co-authored research with the U.S. Food and Drug Administration (FDA) 1.

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FDA Animal Testing Clinical Trials Pharmaceuticals 40

biobide

JUNE 8, 2023

Animal testing has had an influential role in almost every medical breakthrough in the last 100 years. Further, animals are essential in assessing drugs and vaccine safety. Approximately 26 million animals are used in the USA every year for research purposes.

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Animal Testing Research Vaccine Drugs 94

Agency IQ

JUNE 9, 2023

FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity Late last week the FDA released a final guidance document containing recommendations on the nonclinical assessment of potential immunotoxicity for drugs and certain biologics. Nonclinical studies encompass much more than just animal studies.

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FDA Science Small Molecule Immune Response 40

Codon

JULY 21, 2024

Xander Balwit offers concrete proposals for raising the welfare of animals used in biomedical research for our final article in Issue 03. With a little encouragement, these animals develop preconditions towards cancer, Huntington's, Rheumatoid arthritis, Parkinson’s, sleep and memory disorders, addiction, and more.

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Research Engineering Disease Science 122

Agency IQ

MARCH 7, 2024

Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates Congressional appropriators this week released the text of the legislation that is set to provide FY2024 funding for the FDA, following a short-term continuing resolution (CR) to fund the agency and related Departments through date.

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FDA Packaging Science Drugs 40

Codon

MARCH 14, 2023

After reading dozens of papers on this topic, I can’t help but feel that I wasted part of my life injecting chubby mice with drugs. Mice and rats account for 95 percent of all animals used in biomedical research. For every 5,000 drug compounds tested in mice, five move into human studies. Free-range mice?

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DNA Laboratories Engineering Animal Testing 52

Codon

JUNE 2, 2024

Read our full Editors’ Note and preview upcoming articles by clicking here. Read this article on our website by clicking here. Without mouse models, we may never have developed polio and meningitis vaccines, organ transplants, GLP-1 drugs, gene therapies , or any other number of transformative treatments.

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Laboratories Research Disease Science 133

Drug Target Review

APRIL 9, 2025

In the fast-moving world of drug discovery and vaccine development, the most transformative breakthroughs often emerge where cutting-edge science meets bold innovation. Rademacher explained that their approach bypasses the need for traditional animal testing: Everybody asks us why we don’t test our vaccines in monkeys and rabbits.

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Virus Vaccine RNA Trials 95

Agency IQ

JULY 12, 2024

A closer look at the seven new proposed regulations Stage of Rulemaking Title Estimated Publication Synopsis Proposed Rule Amendments to the Current Good Manufacturing Practice Regulations for Drug Products February 2025 FDA is proposing to amend the Current Good Manufacturing Practice Regulations for Drug Products.

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Regulations FDA Science Production 40