Animal Testing Clinical Development Drug Development 
The Pharma Data
AUGUST 1, 2025
This partnership brings together Altasciences’ extensive expertise in preclinical research and early clinical development with VoxCell’s groundbreaking tissue engineering technology, promising to deliver a more human-relevant, predictive, and efficient drug development paradigm.
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.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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.
Drug Target Review
SEPTEMBER 26, 2023
Another area in need of attention is central nervous system (CNS)-safety testing. 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.
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.
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).
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.
Expert insights. Personalized for you.
Let's personalize your content