Drug Target Review

APRIL 7, 2025

As biomarkers become increasingly relevant in indicating the workings and effects of novel therapies, their potential as valuable clinical and regulatory endpoints is also gaining recognition. Biomarkers can play a crucial role throughout clinical development, especially in early phases. Clinical Pharmacology and Therapeutics.

Clinical Development 59

Clinical Development Clinical Trials Clinical Pharmacology Trials 59

Alta Sciences

FEBRUARY 19, 2025

Food and Drug Administration (FDA) issued two guidance documents outlining the necessary evaluations during the clinical development of oligonucleotide therapeutics: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics and Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics .

Drug Development 52

Drug Development Clinical Pharmacology Immune Response Drugs 52

Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development 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.

Pharma Companies 111

Pharma Companies Licensing Licensing Disease 111

Metabolite Tales Blog

JULY 5, 2023

With metabolic stability in mind, we take a look at the metabolism of some FDA approved synthetic macrocyclic drugs, and a few of those that were/are in clinical development where metabolism data was available. Drug Hunter article, June 2023. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION. Balazs et al.,

Drugs 52

Drugs Metabolic Stability FDA Approval Treatment 52

Metabolite Tales Blog

JULY 5, 2023

With metabolic stability in mind, we take a look at the metabolism of some FDA approved synthetic macrocyclic drugs, and a few of those that were/are in clinical development where metabolism data was available. Drug Hunter article, June 2023. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION. Balazs et al.,

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

Agency IQ

DECEMBER 11, 2023

Progression-free survival (PFS) has been used for accelerated approval, traditional approval, and for measuring direct clinical benefits in certain circumstances. [ For a more complete discussion of endpoints in oncology clinical trials, see this recent AgencyIQ article.

FDA 40

FDA Science Clinical Trials Trials 40

Agency IQ

SEPTEMBER 15, 2023

FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. First, Cathy Gelotte, a clinical pharmacology consultant, made the case that low bioavailability does not necessarily indicate a lack of efficacy.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40