The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development 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. Author: Jayesh Patel , Principal Scientist, Pharmacokinetics

Clinical Pharmacology 52

Clinical Pharmacology Drug Development Pharmacokinetics Drugs 52

Alta Sciences

OCTOBER 30, 2023

Podcast : FDA Guidance for Industry Psychedelic Drugs Extensively studied for potential therapeutic efficacy, psychedelic drug development comes with its own set of clinical development requirements. Read the blog. Watch the video. Read the fact sheet. Watch it now. The Altascientist : Issue No.

Science 52

Science Clinical Trials Pharmacokinetics Clinical Pharmacology 52

LifeSciVC

APRIL 24, 2024

There is a continuum of evidence for a given target – at one end are novel targets with some evidence of importance in disease, and at the other end are “de-risked” targets where the biology is precedented with an approved product or late-stage clinical asset(s). based on “tool” molecule precedent.

Production 117

Production Small Molecule Regulations Trials 117

PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved. 2021 [cited 16 December 2021].

Drugs 52

Drugs FDA Approval Pharmacokinetics Drug Development 52

Metabolite Tales Blog

APRIL 4, 2023

In this follow-up blog, “Metabolism of 2022 FDA approved small molecule drugs part 2”, we dig into the other drugs in this set that are cleared by multiple CYPs, mixed phase mechanisms and through involvement of gut metabolism (see Table 1 at the end of this blog). Dermavant’s tapinarof is one such friend. Acta Pharm Sin B.

Small Molecule 52

Small Molecule FDA Approval FDA Drugs 52

Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues. Asia, and Europe.

Drug Development 52

Drug Development Treatment FDA Approval Drugs 52

Metabolite Tales Blog

JANUARY 23, 2024

Pharmacokinetics and Disposition of Momelotinib Revealed a Disproportionate Human Metabolite—Resolution for Clinical Development. Pharmacokinetics and Metabolism of Nirmatrelvir. [link] [9] Patent EP1242061B1. link] [10] FDA prescribing information for gepirone. link] [11] Zheng et al., Blood 129(13): 1823-1830.

Small Molecule 52

Small Molecule FDA Approval FDA Pharmacokinetics 52