Drug Target Review

MARCH 24, 2025

To understand the significance of this goal, it is important to recognise the current drug development process. This uncertainty contributes to the high failure rate and enormous costs of drug development. Currently, understanding these aspects requires extensive animal testing followed by human trials.

Clinical Trials 59

Clinical Trials Animal Testing Drugs Pharmacokinetics 59

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. FDORA § 3209(a)(1). FDORA § 3209(a)(2). 42 U.S.C. §

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays Clinical Trials 64

biobide

JUNE 8, 2023

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

Animal Testing 83

Animal Testing Clinical Trials Drugs Drug Development 83

Predictive Oncology

AUGUST 8, 2024

A recent white paper released by Predictive Oncology’s highlights the challenge of late-stage clinical trial failures and the company’s ability to better navigate those obstacles and increase the probability of technical success which is a key metric in target selection, clinical trial design and pipeline replenishment.

Drug Development 52

Drug Development Clinical Trials Animal Testing Trials 52

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.,

Animal Testing 98

Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

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. What is a Pre-Clinical CRO? over this period. over this period.

Clinical Research 52

Clinical Research Clinical Trials Research Trials 52

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.

Drugs 111

Drugs FDA Disease Animal Testing 111