Drug Target Review

MARCH 17, 2025

This is based on the traditional model of occupancy-driven pharmacology, where a drug’s therapeutic effects are directly related to the time it occupies its target. The drug’s pharmacokinetics (PK) and pharmacodynamics (PD) are closely linked.

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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.,

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Metabolite Tales Blog

APRIL 10, 2024

The next blog will complete our commentary on metabolism of small molecule drugs approved in 2023. Note that where Hypha may have been involved in any of the projects described, no details on metabolites other than what is publicly available have been disclosed in this article. Clin Pharmacokinet. 2023; 62(12):1765-1779.

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Agency IQ

JULY 28, 2023

Physiologically-based pharmacokinetic (PBPK) models are defined by FDA as drug development tools that mathematically integrate physiological, physicochemical, and drug-dependent preclinical and clinical information to predict an investigational drug’s absorption, distribution, metabolism, excretion (ADME), and pharmacokinetics (PK).

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Agency IQ

FEBRUARY 2, 2024

The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996. The document has been updated over time to implement advances in understanding cancer and drug development. In 2005, the guidance was updated to include non-cytotoxic drugs were gaining in importance.

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Alta Sciences

SEPTEMBER 13, 2023

COMMONLY USED PAIN MODELS As pain models continue to expand, there are still many tried and tested ways to achieve the most accurate results possible, such as pain stimulation, pharmacodynamics (PD), and pharmacokinetics (PK) for early phase analgesic trials. At Altasciences , we have extensive experience testing various pain models.

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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. This study is planned to start in late 2024 and conclude in late 2025.

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PPD

JUNE 20, 2023

As some drug development organizations right-size their workforces , a strong CRO partner will rehire your talent — avoiding destabilization of your clinical research — via rebadging through functional service provider (FSP) engagements. The drug development industry is undoubtedly in a season of change.

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Agency IQ

DECEMBER 11, 2023

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time.

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Agency IQ

OCTOBER 20, 2023

In terms of general drug development considerations during the early phase, sponsors should consider obtaining Phase 1 data that demonstrate that the candidate drug has adequate penetration to the outer skin layers, after consultation with the agency about drug penetration study technique.

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PerkinElmer

JUNE 3, 2022

Writing in JACS , the researchers concluded: “Based on the broad-spectrum antiviral effect combined with promising selectivity and in vitro pharmacokinetic profile, the scaffold represented by [this compound] is one of the most promising for development of an antiviral drug targeting SARS-CoV-2.”

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Agency IQ

MAY 17, 2024

How have pre-submission meetings for generic drug applicants changed under GDUFA III? Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. The generic drug user fee program is currently on its third iteration (i.e.,

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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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Agency IQ

DECEMBER 11, 2023

For a more complete discussion of endpoints in oncology clinical trials, see this recent AgencyIQ article. Still, the article served to reinforce the primacy of OS as a primary endpoint in oncology trials. However, the proper use of some non-OS endpoints has been called into question in recent years.

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Agency IQ

JUNE 9, 2023

BY RACHEL COE, MSC JUN 6, 2023 5:00 PM CDT What are nonclinical studies and when are they conducted in drug development? Though the legislation had little to no impact on the actual operations of sponsors, it brought increased public awareness to a topic that FDA has been slowly working to modernize for years.

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Agency IQ

SEPTEMBER 22, 2023

The agency lists several situations in which mechanistic data may be suitable confirmatory evidence, like when a drug’s mechanism of action corrects an enzymatic or genetic defect caused by a single gene and/or enzyme defect. (3) We also expect that some of these confirmatory evidence types will be used far more sparingly than others.

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Agency IQ

FEBRUARY 23, 2024

Overdue EMA reflection paper on drug dosing in obesity introduces more questions than answers Although the prevalence of overweight and obesity in Europe exceeds 50%, the EMA does not currently offer guidance to sponsors on investigating the effects of obesity during drug development.

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Agency IQ

AUGUST 16, 2024

Just a few months after the draft guidance on dose optimization was published, a handful of OCE staff, including its leaders, published a landmark article in March 2023. [Read the analysis of the comments submitted here] Since then, this topic has continued to be a priority for the FDA. To be [administered with] food or not to be?

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Agency IQ

FEBRUARY 12, 2024

Another guidance will focus on pharmacokinetics in pregnancy, likely replacing a 2004 guidance document that the FDA never finalized, while a guidance the creation of a “REMS Logic Model” framework is meant to “link program design with assessment” – something called for in the most recent PDUFA VII commitment letter.

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Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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Drug Target Review

JANUARY 20, 2025

The oncology drug development landscape is evolving rapidly, driven by the deployment of targeted therapies in precision medicine and regulatory initiatives like the FDAs Project Optimus. It also covers strategies for drug developers who have yet to identify a biomarker, helping them advance their programs effectively.

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Agency IQ

JUNE 28, 2024

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time.

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