Clinical Development Clinical Pharmacology Production 
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. Listed Drugs [LDs]) and/or published scientific literature.
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.
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Conversations in Drug Development Trends
FEBRUARY 21, 2024
During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study.
FDA Law Blog: Drug Discovery
DECEMBER 6, 2024
Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. The draft guidance states that only one 90-minute pre-BLA meeting will typically be granted for a specific product or indication planned for an original marketing application.
The Pharma Data
NOVEMBER 8, 2020
HK) (“Pharmaron”), a fully integrated contract research and manufacturing organization offering laboratory, CMC and clinical development services for the life science industry, announced today that it has acquired 100% of the equity of Absorption Systems for up to US$137.5 BEIJING–( BUSINESS WIRE )– Pharmaron Beijing Co.,
The Premier Consulting Blog
JUNE 18, 2023
Figure 1: Comparison of Clinical Trial Designs The Prelude to Applying In Silico Trials for Rare Diseases In silico clinical trials have been recognized by the FDA as useful tools in advancing personalized treatment and streamlining randomized controlled trials.
The Pharma Data
OCTOBER 1, 2021
The research, which spans clinical, health economics and outcomes research, translational, clinical pharmacology and preclinical presentations, highlights the breadth and depth of the company’s data on deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor, also because the emerging dermatology pipeline.
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