This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drugdevelopers for phase I trials, second only to navigating regulatory compliance (- 38 percent). Biomarkers can play a crucial role throughout clinicaldevelopment, especially in early phases.
Regulatory Guidance for Oligonucleotide Bioanalysis in DrugDevelopment pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.
The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinicalpharmacology.
In this blog, we explain the role of clinicalpharmacology in drugdevelopment and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.
Since its launch in 2021, Project Optimus has been reforming the dose optimization and dose selection paradigm in oncology drugdevelopment. To address this challenge, the FDA Oncology Center of Excellence initiated Project Optimus. With consensus of multiple stakeholders on “why” the change is needed, the speakers focused on “how.”
The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinicaldevelopment should emphasize sensitivity over specificity in CNS effects.
How do AI-enhanced approaches accelerate the drugdevelopment process for rare diseases? AI holds the potential to revolutionise different aspects of healthcare, particularly in the realm of clinical trials. At Debiopharm, he has overseen both preclinical and clinicalpharmacology of assets from phase I to III.
Find out what the key factors are when developing nonclinical cell and gene therapies, including expert approaches to vindicating complex challenges, making your studies more efficient, and maximizing translational opportunities to first-in-human (FIH) trials. Read or listen now. Watch the video. Listen here. The Altascientist : Issue No.
This has opened new opportunities in pharmaceutical drugdevelopment, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.
I am a pharmacist by training and continued with a PhD in ClinicalPharmacology. However, my goal was all the time to work with drugdevelopment in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.
Older adults: While certain age-associated factors like comorbidities, age, and weight can be adjusted using standard clinicalpharmacology methods; reviewers have noted that these factors do not entirely adjust for the differences we see in older patient populations.
OncoSec Medical – Sanda Aung was named chief clinicaldevelopment officer for OncoSec Medical Incorporated. Trevi Therapeutics – Shashank Rohatagi was named vice president of Pharmacology and Clinical Phrarmacokinetics. She was also CSO at Adjuvant Partners. Farrell Simon joins Trevi as head of U.S. Source link.
We organize all of the trending information in your field so you don't have to. Join 15,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content