Clinical Pharmacology Drug Development Packaging 
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.
Drug Target Review
AUGUST 7, 2024
The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies. This continued innovation highlights the complexity of the drug development process, particularly as the field is highly regulated by health authorities around the world.
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Alta Sciences
SEPTEMBER 20, 2023
Once samples are validated, this will conclude the IND package” said Kyle Klepner, Senior Scientist, Study Director, Safety Assessment, at Altasciences. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions.
The Premier Consulting Blog
SEPTEMBER 11, 2024
The 505(b)(2) submission for Bendeka included a complete chemistry, manufacturing, and controls (CMC) package, but relied on the drug master file (DMF) for Treanda. The overall development strategy for GT123 was to include a complete CMC package. daily versus four times daily dosing).
The Premier Consulting Blog
NOVEMBER 4, 2023
The impact of the device on the drug product quality attributes and safety are suitable issues for discussion in the pre-IND meeting. In the steps leading up to a pre-IND meeting, the physicochemical properties of the API used in nonclinical studies should be comparable to those intended for clinical studies.
Agency IQ
MAY 3, 2024
Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)
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.
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