Metabolite Tales Blog

JANUARY 23, 2024

Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. References [1] 2023 Novel Small Molecule FDA Drug Approvals. Health Sci Rep. 6(10):e1610.

Small Molecule

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. This is where pharmacokinetic (PK), pharmacodynamic (PD) , and toxicokinetic (TK) analyses step in.

Pharmacokinetics

Molecular Design

FEBRUARY 7, 2023

The FDH is covered in the S2010 (see Box 1 and 2) and B2013 articles and, given that the targets of small molecule drugs tend to be intracellular, I’ll direct you to the excellent Smith & Rowland perspective on intracellular and intraorgan concentrations of drugs.

Pharmacokinetics

Alta Sciences

APRIL 17, 2024

In this blog article, we review some of these areas of investigation where Altasciences has robust expertise and solution offerings. According to a 2022 article published in Molecular Psychiatry, treatment resistance affects 20 to 60% of patients with psychiatric disorders. Asia, and Europe.

Drug Development

The Pharma Data

NOVEMBER 4, 2020

The article, entitled “Burden of Illness in Alopecia Areata: A Cross-Sectional Online Survey Study,” is available online at: [link]. CTP-692: An Investigational Adjunctive Treatment for Schizophrenia. CTP-692 Phase 2 Enrollment Complete.

Pharmaceuticals

Agency IQ

FEBRUARY 23, 2024

Additionally, this approach is generally no longer applicable to new treatments that are more targeted in their effects, such as immunotherapies and targeted small molecule therapies. This has spawned a movement focused on optimizing dose selection in oncology drug development.

Science

Agency IQ

JULY 26, 2024

in equipment) for products that are more complex or aren’t as well-characterized, such as antibody drug conjugates or recombinant DNA products, will be considered higher risk than they would if the change was made to the production of standard, small molecule products. Any CMC changes (e.g.,

Biosimilars

Agency IQ

JUNE 9, 2023

However, this guideline is primarily intended to provide recommendations on evaluating the immune system’s response to small molecule drugs. The guidance contains recommendations for small molecule drugs, as well as any biological products that fall within CDER’s purview.

FDA

Codon

APRIL 2, 2023

This is Codon Digest, a weekly roundup of research papers, news articles, and industry highlights about engineered biology. Read Small-molecule aptamer for regulating RNA functions in mammalian cells and animals. Thanks for skimming. ❤️ Subscribe to support human writers. Ricciardi M.J. Cell Systems. Fukunaga K.

DNA

Agency IQ

DECEMBER 11, 2023

In 2015, the FDA, along with the American Association for Cancer Research (AACR), held a workshop on dose optimization for small molecules. For a more complete discussion of endpoints in oncology clinical trials, see this recent AgencyIQ article. Read AgencyIQ’s analysis of that paper, and the larger issues, here.

FDA

Metabolite Tales Blog

NOVEMBER 13, 2024

References [1] Pharmacokinetics, disposition, and biotransformation of the cardiac myosin inhibitor aficamten in humans. 2] Pharmacokinetics, mass balance, tissue distribution, metabolism, and excretion of [14C]aficamten following single oral dose administration to rats. Drug Metab Pharmacokinet. Drug Hunter article.

Pharmacokinetics

Drug Target Review

APRIL 25, 2025

3 These models are pivotal for offering key predictive insights into the clearance of metabolically stable small molecules, maintaining phase I and II metabolic activities for up to four weeks. 9,10 According to IQ-MPS recommendations, liver-on-chip systems can differentiate between toxic and non-toxic small molecule analogues.

Clinical Development

New Drug Approvals

MAY 11, 2025

This article incorporates text from this source, which is in the public domain. ^ “Reata Pharmaceuticals Announces FDA Approval of Skyclarys (Omavaloxolone), the First and Only Drug Indicated for Patients with Friedreich’s Ataxia” Reata Pharmaceuticals Inc. 2] [5] It is taken by mouth. [2] 2] [5] It is taken by mouth. [2]

FDA