Clinical Pharmacology Drug Development Pharmacokinetics 
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.
Alta Sciences
AUGUST 28, 2023
s novel, proprietary cytoprotective drug candidate, CMX-2043, for the treatment of acute TBI. The trial was performed at Altasciences’ clinical facility in Montréal. The results of the trial showed a well-characterized pharmacokinetic profile, demonstrating dose proportionality over the ranges studied. About Ischemix, Inc.
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The Premier Consulting Blog
SEPTEMBER 11, 2024
This nonclinical study required good manufacturing practice (GMP) drug product, sham product, and vehicle to qualify the novel excipient used to modify absorption. From a clinical pharmacology perspective, the sponsors also needed to establish a scientific bridge for relying on the data contained in the product labeling of the LD.
Agency IQ
JULY 28, 2023
This proposal is an exciting example of how new approaches at the forefront of clinical pharmacology can be leveraged to address the problems being discussed in other forums (e.g., FDA’s 2020 draft guidance discusses PBPK analyses for oral drug product development. Read the full AgencyIQ analysis here.
Agency IQ
DECEMBER 1, 2023
As before, the guidance provides recommendations on drug development for COVID-19 across five domains: population, trial design, efficacy endpoints, safety considerations and statistical considerations. drug-drug interactions) and intrinsic factors (e.g.,
Agency IQ
FEBRUARY 23, 2024
Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.
New Drug Approvals
SEPTEMBER 13, 2024
4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1]
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