Drug Target Review

MARCH 18, 2024

How do recent advancements in bioprinting technology promise to revolutionise the traditional drug development process, in terms of cost and timeline? By enabling a more direct assessment of drug interactions with human tissue, bioprinting can streamline the path from lab to market.

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Marketing Animal Testing Engineering Drug Development 59

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. What are nonclinical studies and when are they conducted in drug development?

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FDA Animal Testing Science Drug Development 52

Drug Target Review

SEPTEMBER 10, 2024

The current landscape of protein drug development is characterised by accelerated timelines where new drugs are approved in months rather than years. Hence, in many cases an earlier IND may be prevented by the timely provision of representative Drug Substance (DS) to execute such toxicology studies.

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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. over this period.

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Drug Target Review

SEPTEMBER 26, 2023

CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact.

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Drugs FDA Disease Animal Testing 111

Drug Target Review

OCTOBER 3, 2024

In 2024 alone, almost 50 antibody drug candidates are anticipated to enter regulatory review, the majority of which are mAbs. Aside from the advent of complex antibody-based drugs, the industry is facing some additional changes which are shaping drug development. 1975 Aug;256(5517):495–7. Antibodies to watch in 2024.

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The Pharma Data

JANUARY 11, 2021

This publication fortifies the body of evidence demonstrating how PhysioMimix technology can rapidly generate human-relevant, robust data that is clinically translatable and predictive, facilitating more insightful, accurate and cost-effective drug development, for improved clinical success.

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The Pharma Data

MAY 15, 2023

By mirroring human and disease biology more accurately than animal models, they can also help reduce the reliance on animal testing. To learn more about the Institute of Human Biology and how Roche is pioneering new approaches for drug discovery and development, visit our IHB website and read this story.

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Animal Testing Pharmaceuticals Disease Research 40

FDA Law Blog: Drug Discovery

SEPTEMBER 27, 2023

The issues appropriate for an INTERACT meeting typically relate to IND requirements, such as questions about IND-enabling studies, complex manufacturing technologies or processes, development of innovative devices used with a drug or biologic, or the use of New Approach Methodologies (methods to be used in place of traditional animal testing).

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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.

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The Premier Consulting Blog

APRIL 25, 2023

As a result, the FDA is now required to consider alternatives to animal testing, such as in vitro , in silico , and in chemico tests and models. In this blog post, we examine several alternative approaches to animal testing and how the FDA handles the application of these methods in specific scenarios.

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FDA Animal Testing Pharmacokinetics Pharmaceuticals 52

Codon

JUNE 2, 2024

” It’s an uncharitable take, but when drugs fail as often as they do despite animal testing, it’s not hard to see the JAX mice as a metaphor for a biomedical enterprise cloistered away from the real world. In cancer, the focus of Little’s ambitions, mouse models leave much to be desired.

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Instead, this guidance highlights questions about species, animal model, and product selection for nonclinical programs as well as several aimed at helping to understand the purpose and importance of POC, toxicity, and biodistribution studies.

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Therapies FDA Production Disease 59

Drug & Device Law

JULY 21, 2022

After recounting the many laws that protect animals generally and animals used in research specifically, NABR warned that extending habeas rights to animals would upset the current balance between animal welfare and critical human interests.

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