Animal Testing, Regulations and Trials

Considering the use of animal models in drug development

Drug Discovery World

AUGUST 13, 2024

There are serious ethical and scientific questions about the use of these models that need addressing and discussing amongst regulators, researchers, scientists and others involved in drug development. Since the pandemic there has been a reduction in the availability of non-human primates, which has hindered trials and drug development.

Drug Development

Drug Development Animal Testing Regulations Drugs

New Alternative Methodologies and Their Applications in Drug Discovery and Development

biobide

SEPTEMBER 29, 2023

Where possible, NAM s seek to avoid the use of animal testing or at least to reduce it. However, reports drawn up as recently as June 2023 still emphasize the necessity of animal testing at some point as we are still far from understanding and reproducing all the variables present in a whole organism in an in vitro or in silico model.

Animal Testing

Animal Testing Drugs Pharmacokinetics Regulations

Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs

Agency IQ

JUNE 28, 2024

New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time.

Trials

Trials Marketing Clinical Trials Regulations

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research

Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. 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.

Clinical Research

Clinical Research Research Clinical Trials Laboratories

Advanced 3D cell-based technologies

Drug Target Review

SEPTEMBER 19, 2023

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. Prior to this European Union Parliament, in 2021, voted for animal testing phase out. The US FDA Modernisation Act 2.0., Nature Cancer. 2022;3(4):418-36. Frontiers in Physiology.

Animal Testing

Animal Testing Clinical Trials Pharmaceutical Companies FDA

CN Bio named winner with most impactful industry collaboration

Drug Discovery World

NOVEMBER 23, 2023

Coupled with increasing awareness around ethical considerations and the increasing cost of animal studies, there is growing interest in New Approach Methodologies (NAMs), such as OOC, to provide effective, predictive preclinical models.

Animal Testing

Animal Testing FDA Clinical Trials Government

Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Agency IQ

JUNE 9, 2023

The guidance looks very different from the draft that was published in February 2020, including changes in the scope of the guidance, its sponsorship, and the removal of all mentions of nonhuman primates for animal testing. Nonclinical studies encompass much more than just animal studies.

FDA

FDA Science Small Molecule Immune Response

How Lume Whole Body Deodorant Was Inspired by a Genetic Disease

PLOS: DNA Science

APRIL 4, 2024

Fishy Regulations Lume falls under the cosmetic category at FDA and so needn’t have undergone clinical trials, because it doesn’t treat an illness or condition. If each ingredient is recognized as safe, then manufacturing complies with FDA regulations. What’s the stink test? Remember the statins?

Disease

Disease Testimonials Production FDA

Human neuronal cells: possibilities in drug safety testing

Drug Target Review

SEPTEMBER 26, 2023

Our approach to seizure liability screening is especially pertinent in the context of the recent FDA modernization act which allows applicants to use methods other than animal testing to establish drug safety and effectiveness. Ther Innov Regul Sci. Regul Toxicol Pharmacol RTP. 2018;53(4):519–25. 2023 Mar;139:105345.

Drugs

Drugs FDA Disease Animal Testing

CN Bio’s PhysioMimix Technology Receives FDA Recognition

The Pharma Data

JANUARY 11, 2021

The first co-published, peer-reviewed research paper between a commercial MPS provider and a regulator, demonstrates that data derived using CN Bio’s proprietary PhysioMimix system is appropriate for use in drug safety and metabolism applications, evidencing its enhanced performance versus standard techniques.

FDA

FDA Animal Testing Clinical Trials Pharmaceuticals

Raising Welfare for Lab Rodents

Codon

JULY 21, 2024

It may seem that if researchers are sufficiently concerned about the welfare of lab animals, the best thing to do would be to stop using animals altogether. However, a multitude of factors—from institutional inertia to a global animal-testing industry worth billions of dollars —make this outcome unlikely.

Research

Research Engineering Science Disease

Everything Wrong with Mouse Studies (Kinda)

Codon

MARCH 14, 2023

The ALS Therapy Development Institute, located just ten minutes from my home in Cambridge, once tested more than 100 potential drugs to slow ALS progression in mice, all of which had been reported to be helpful in other studies. ” About 6% of all mouse genes are regulated in sex-specific ways. Free-range mice? .”

DNA

DNA Laboratories Animal Testing Engineering

Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

MAY 10, 2023

Dr Megan MacBride and Dr Caroline Horizny Mitchell , Taconic, examine recent changes to animal testing in drug design. This stage is more highly regulated and consists of both preclinical testing and clinical trials. Drug discovery and development is an arduous process that can cost upwards of $2.6

Small Molecule

Small Molecule Pharmaceutical Companies Animal Testing Pharmaceuticals

Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

Agency IQ

MARCH 7, 2024

Further, the agency would need to make a separate table finding “at least $8,500,000,” for cosmetics regulation implementation ($7 million of that) and work on finding alternatives to animal testing ($1.5 Next: Enriched Enrollment, Randomized Withdrawal (EERW) clinical trial designs.

FDA

FDA Packaging Science Drugs

Drug Discovery Digest

Considering the use of animal models in drug development

New Alternative Methodologies and Their Applications in Drug Discovery and Development

Trending Sources

Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research

Advanced 3D cell-based technologies

CN Bio named winner with most impactful industry collaboration

Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

How Lume Whole Body Deodorant Was Inspired by a Genetic Disease

Human neuronal cells: possibilities in drug safety testing

CN Bio’s PhysioMimix Technology Receives FDA Recognition

Raising Welfare for Lab Rodents

Everything Wrong with Mouse Studies (Kinda)

Accelerating NDA filing through faster carcinogenicity assessment

Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

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