biobide

MAY 18, 2023

Animal testing for the benefit of medical and scientific research has been taking place for hundreds of years. However, testing on animals has always been and will continue to be an ethical issue.

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Animal Testing Pharmaceuticals Research Drugs 78

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

In effect, the revisions to the FD&C Act and the PHS Act are designed to encourage the use of alternatives to animal testing not eliminate animal testing in drug development. adequate to justify the proposed clinical testing.” The pre-existing statutory language did not require animal testing.

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Animal Testing Biosimilars Cell Based Assays FDA 64

Reprocell

NOVEMBER 1, 2022

Pharma companies are legally required to test novel drugs in animal models before beginning human trials. And while animal testing has progressed thousands of therapeutics that we use today, it is not without its experimental and ethical downfalls.

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Animal Testing Pharma Companies Laboratories Science 52

Agency IQ

AUGUST 4, 2023

Commission redoubles commitment to reduce animal testing in response to Citizens’ Initiative The European Commission provided its mandatory response to a citizens’ petition this week urging faster action to reduce and ultimately eliminate animal testing within the cosmetics and chemical sectors.

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Agency IQ

AUGUST 4, 2023

Commission redoubles commitment to reduce animal testing in response to Citizens’ Initiative The European Commission provided its mandatory response to a citizens’ petition this week urging faster action to reduce and ultimately eliminate animal testing within the cosmetics and chemical sectors.

Animal Testing 40

Animal Testing Regulations Production Research 40

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.

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Animal Testing Drugs Pharmacokinetics Regulations 106

Drug Discovery World

JANUARY 18, 2023

Changes to rules for animal testing . Animal models currently dominate when estimating bioavailability, but evidence has shown these models are poor predictors, in part due to inherent physiological and metabolic differences. . Bioavailability is defined as the fraction of drug reaching the bloodstream.

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FDA Animal Testing Research Drug Development 130

Drug Target Review

JULY 6, 2023

Animal testing plays a significant role in pre-clinical research and therefore requires the use of millions of animals. million scientific procedures involving live animals were carried out in 2020. million scientific procedures involving live animals were carried out in 2020. In Britain, 2.88 In Britain, 2.88

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Animal Testing Drugs Clinical Trials Clinical Research 105

biobide

JUNE 8, 2023

It is fast becoming a cost-effective and efficient alternative to animal testing. The in silico method represents an increasing role in drug discovery as technology becomes more sophisticated. It can be used in all stages of drug discovery, from screening to pre-clinical trials and greatly reduces drug development time.

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Animal Testing Clinical Trials Drugs Drug Development 83

Drug Discovery World

JANUARY 26, 2024

The convergence of AI with bioengineering technologies like the patient-on-a-chip system is setting a new standard, offering a more accurate, cost-effective and efficient approach to drug discovery, ultimately accelerating the delivery of life-saving drugs to the market.”

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Drug Discovery World

MARCH 20, 2024

The post Beyond animal testing: The rise of organoids in toxicology research appeared first on Drug Discovery World (DDW). Backed by the FDA Modernization Act 2.0, it’s leading a shift towards efficient, human-focused research, promising faster and more successful treatment advancements.

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Animal Testing Research Clinical Trials Drug Development 147

Drug Discovery World

SEPTEMBER 25, 2023

The vaccine produced robust antibody responses in animal testing. FluMos-v2 is designed to induce antibodies against many different influenza virus strains by displaying part of the influenza virus hemagglutinin (HA) protein in repeating patterns on self-assembling nanoparticle scaffolds.

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Drug Target Review

MARCH 18, 2024

These models can be used for more efficient and effective drug testing early in the development process, potentially reducing the need for animal testing and later-stage human trials that are both costly and time-consuming.

Marketing 59

Marketing Animal Testing Engineering Drug Development 59

biobide

AUGUST 18, 2023

With an increased focus on animal welfare , the beauty industry has undergone a shift towards the 3Rs Principle application and all surrounding regulations. In 2004 the European Union (EU) introduced a ban on animal testing on finished products.

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Regulations Animal Testing Production Treatment 92

Agency IQ

JANUARY 12, 2024

The framework supports EPA’s mandate to develop and implement alternative test methods and strategies, or new approach methodologies (NAMs), that do not require vertebrate animal testing for assessing risk of injury to health or the environment. Fill out the form to read the full article.

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Animal Testing 59

Drug Discovery World

NOVEMBER 9, 2022

In silico modelling for CYP in preclinical species can also reduce animal testing in toxicology studies, making trials quicker, less expensive, and more ethical. .

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Animal Testing Drugs Trials Drug Development 130

Crown Bioscience

APRIL 12, 2023

The development of new drugs and biological products has traditionally mandated animal testing, but the FDA Modernization Act 2.0 allows for alternative non-clinical testing, allowing reliable alternatives for drug discovery and biological product applications.

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Animal Testing Drugs FDA Production 52

FDA Law Blog: Biosimilars

MARCH 19, 2024

using phantoms, ex vivo animal tissue models, and/or in vivo animal testing), computationally, and/or clinically. When in vivo animal testing is needed, tests should follow good laboratory practices and the animal model should be representative of the intended clinical application.

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Animal Testing Laboratories Marketing Regulations 59

Drug Discovery World

FEBRUARY 2, 2023

The NABR clarifies: “The FDA previously had the authority to allow non-animal data to be considered during safety and efficacy reviews of new drugs and previously issued guidance regarding such. It does not eliminate animal testing for drugs nor does it state or imply that animal testing is unnecessary.

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Animal Testing FDA Clinical Trials Cell Based Assays 130

Agency IQ

NOVEMBER 27, 2023

The next key area concerns the ongoing shift away from animal testing. For example, under the REACH (1907/2006/EC) and CLP (1272/2008/EC) regulations, NAMs are generally only used to replace animal testing for hazard identification and classification of skin sensitizers.

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Drug Discovery World

MAY 9, 2023

The recent passage of the FDA Modernization Act, which removed the requirement for animal testing when suitable alternatives are available, has highlighted the inadequacy of animal models most often used for in vivo research.

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Reprocell

MARCH 6, 2023

expands the range of models that can be used to test a compound before clinical trials. 1 Under this new law animal testing can still be used, but alternative testing methods now also represent a legitimate option. With support from over 200 organizations, the "FDA Modernization Act 2.0"

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

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Drug Discovery World

FEBRUARY 12, 2024

Dr Pandora Pound , Fellow Oxford Centre for Animal Ethics explores the hinderances of animal testing in pharma and why new technologies such AI, genomics and synthetic biology c an further drug development.

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Animal Testing Disease Trials Research 147

Drug Discovery World

JANUARY 21, 2024

He will also explain the importance of this innovation as a way to mitigate the high failure rates in clinical trials, which historically see 92% of drugs fail despite passing animal tests, leading to significant financial and time losses in the industry (approximately $53 billion for pharma companies annually).

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Vaccine Computational Chemistry Animal Testing Engineering 130

Drug Target Review

MARCH 11, 2024

How can this finding potentially reduce the reliance on animal testing in the field of cancer drug testing? 3D printing allows innovators to produce complex structures and intricate organ models, which can be used to study diseases and test new therapies in a more realistic and efficient manner.

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Animal Testing Therapies Clinical Trials Research 111

Drug Discovery World

MAY 25, 2023

Rodgers said that the FDA Modernisation Act had encouraged a reduction in animal testing and opened up new opportunities, allowing human disease models technology to advance at a faster rate.

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Drug Discovery World

JULY 20, 2023

She urged that new methodologies are needed to reduce human and animal testing to establish safety and efficacy. In these types of application, a sponsor is required to take responsibility, though this can be an academic institution.

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Clinical Pharmacology Clinical Trials Drugs Trials 100

biobide

JANUARY 5, 2024

At its core lies a pivotal stride toward more humane and scientifically advanced practices through the authorization for the use of certain alternatives to animal testing in Drug safety and efficacy investigations. It arises from a collective acknowledgment of ethical concerns surrounding the use of animals in Research.

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Animal Testing FDA Pharmaceuticals Production 59

Agency IQ

OCTOBER 12, 2023

It also found this approach beneficial because it reduces the need for animal testing. In other words, CHP-methyl and chlorpyrifos are close enough in structure to be appropriate for EFSA to leverage data from the latter to inform the regulation of the former, bypassing the need for redundant animal testing in the process.

Regulations 40

Regulations Animal Testing Government Production 40

Agency IQ

JUNE 7, 2024

Like the registration requirement under REACH, this provision has been added to support data sharing for the same substances, to help limit potential data gaps among individual companies and, in turn, decrease the need for resorting to animal testing.

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Regulations Animal Testing Production Marketing 40

Vial

MAY 20, 2024

One of the key challenges that accompanies this early phase of drug development is ensuring the preclinical CRO’s team of scientists select effective tests to accurately evaluate a new drug candidate.

Clinical Research 52

Clinical Research Research Clinical Trials Laboratories 52

FDA Law Blog: Biosimilars

OCTOBER 10, 2023

Bench Model Testing “Testing using model systems with representative materials, geometries, and/or other simulated use parameters to evaluate the implant and demonstrate SE.” We suggest consulting the draft guidance for a few representative examples of situations in which FDA may recommend animal testing.

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FDA Animal Testing Engineering Regulations 45

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. Human model systems are miniature 2D or 3D living ‘replicas’ of human tissues and organs that scientists create from human stem cells.

Animal Testing 40

Animal Testing Pharmaceuticals Disease Research 40

Advarra

JUNE 20, 2023

Because of this, oncology researchers may only have access to minimal existing scientific literature related to cell-based data and animal testing to predict an investigational therapy’s effect on human factors. Often, medical innovations are first explored in oncology research (e.g.,

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Trials Clinical Trials FDA Approval Animal Testing 52

Drug Discovery World

OCTOBER 20, 2023

The latest sponsored DDW Sitting Down With podcast features Professor Jonathan Blackburn, Chief Scientific Officer of Sengenics, who discusses the advantages of functional protein microarrays, challenges to overcome for biomarker discovery, Sengenics ’ new i-Ome Discovery chip, and more.

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Drug Discovery World

OCTOBER 19, 2023

The latest sponsored DDW Sitting Down With podcast features Professor Jonathan Blackburn, Chief Scientific Officer of Sengenics, who discusses the advantages of functional protein microarrays, challenges to overcome for biomarker discovery, Sengenics ’ new i-Ome Discovery chip, and more.

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Production Animal Testing Drugs FDA 130