2024, Disease, Drug Development and Pharmacokinetics

2024

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Considering the use of animal models in drug development

Drug Discovery World

AUGUST 13, 2024

Animal models (AMs) have generally been seen as useful for drug development and biomedical research for many years. They are assumed to closely mimic human disease progression and act as a good testing ground for toxicology studies and pharmacokinetics 1. Drugs developed in animals often fail in human studies.

Drug Development

Drug Development Animal Testing Regulations Drugs

Pharmacokinetics, Pharmacodynamics and Toxicokinetics Demystified

Alta Sciences

JANUARY 31, 2024

Pharmacokinetics, Pharmacodynamics and Toxicokinetics Demystified pmjackson Wed, 01/31/2024 - 14:55 Understanding the effects of a drug, and how it interacts with the body, and vice versa, is critical to ensure it is safe for human use.

Pharmacokinetics

Pharmacokinetics Clinical Trials Drug Development Small Molecule

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Drug Discovery World

Five Promising Treatment Areas in Early-Phase Drug Development in 2024

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.

Drug Development

Drug Development Treatment FDA Approval Drugs

Article FDA Thank You FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version

Agency IQ

DECEMBER 1, 2023

Now, the FDA has issued its first post-PHE version of this guidance Although the previous version of the guidance was revised to remain in effect until March 7, 2024, it has now been replaced. drug-drug interactions) and intrinsic factors (e.g., drug-drug interactions) and intrinsic factors (e.g.,

FDA

FDA Clinical Trials Vaccine Trials

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

166 guidance documents the FDA is actively working on in 2024 (and beyond) The FDA is set to be very, very busy in 2024. We’ve identified a total of 166 guidance documents that are under active development, and have the key details for you below.

FDA

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Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

Agency IQ

FEBRUARY 12, 2024

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year. This week, CDER published its guidance agenda for 2024.

How Improving Diversity Can Benefit Clinical Trials

Alta Sciences

JULY 31, 2024

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025. Tags Clinical Trials Weight 15

Clinical Trials

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Analysis Life Sciences Thank You FDA solidifies its advice on dose optimization for oncology products

Agency IQ

AUGUST 16, 2024

By Rachel Coe, MSC | Aug 12, 2024 6:15 PM CDT Background For decades, sponsors have turned to maximum tolerated dose (MTD) as the primary method for dose selection in oncology. In early-stage development of traditional cytotoxic oncology drugs (i.e., What’s new? To be [administered with] food or not to be?

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Production FDA Science Clinical Trials

Better Late Than Never – Unpacking FDA’s Highly Anticipated (and Long Overdue) Draft Guidance on Diversity Action Plans

FDA Law Blog: Drug Discovery

JULY 9, 2024

The deadline for the Draft Guidance was December 29, 2023, so the draft, issued on June 26, 2024, is about 6 months late under FDORA’s mandate. Although not required by FDORA, FDA encourages sponsors to consider such additional factors, which may support subgroup analyses, when developing DAP goals. intended use population.

FDA

FDA Clinical Trials Disease Trials

Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

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.

Science

Science FDA Trials Clinical Pharmacology

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

FEBRUARY 2, 2024

The revisions flesh out considerations for use of biomarkers at all stages of product development and add new content on rare cancers and platform trial designs. BY KIRSTEN MESSMER, PHD, RAC, KARI OAKES | JAN 31, 2024 9:01 PM CST Regulatory Background Cancer is the second leading cause of death in the E.U. were from cancer.

Clinical Trials

Clinical Trials Trials Treatment Production

Article EMA Thank You Overdue EMA reflection paper on drug dosing in obesity introduces more questions than answers

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.

Drugs

Drugs Clinical Trials Pharmacokinetics Drug Development

Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Agency IQ

DECEMBER 11, 2023

Diagnostic and therapeutic advances in oncology have moved many cancer types into the categories of curable or treatable diseases. That’s why, according to FDA’s Oncology Center of Excellence, the determination of an appropriate endpoint in oncology is based on the specific disease and is highly dependent upon numerous factors.

FDA

FDA Science Clinical Trials Trials

Analysis Life Sciences Thank You FDA just published its Diversity Action Plan guidance. Here’s what you need to know.

Agency IQ

JUNE 28, 2024

The overhauled guidance, which was entirely re-written after FDA obtained new authority from Congress in 2022, offers granular recommendations on how sponsors of both drug and device programs should interpret compliance with the new legal requirements, and also answers questions about how FDA intends to waive certain requirements.

FDA

FDA Science Clinical Trials Production

Drug Discovery Digest

Considering the use of animal models in drug development

Pharmacokinetics, Pharmacodynamics and Toxicokinetics Demystified

Trending Sources

Five Promising Treatment Areas in Early-Phase Drug Development in 2024

Article FDA Thank You FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

How Improving Diversity Can Benefit Clinical Trials

Analysis Life Sciences Thank You FDA solidifies its advice on dose optimization for oncology products

Better Late Than Never – Unpacking FDA’s Highly Anticipated (and Long Overdue) Draft Guidance on Diversity Action Plans

Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Article EMA Thank You Overdue EMA reflection paper on drug dosing in obesity introduces more questions than answers

Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Analysis Life Sciences Thank You FDA just published its Diversity Action Plan guidance. Here’s what you need to know.

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