Drug Target Review

APRIL 7, 2025

For example, transcriptomic processes are showing the potential to identify and track failures in gene expression and gene regulation of amyloid and tau-related biomarkers, understood as precursors to the onset of Alzheimers disease (AD). Clinical Pharmacology and Therapeutics. Clinical Pharmacology and Therapeutics.

Clinical Development 69

Clinical Development Clinical Trials Clinical Pharmacology Trials 69

Drug Target Review

JULY 4, 2023

These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. 1 Regulators invest significant consideration balancing quality-of-life measures with overall survival when assessing novel oncology treatments. 3D rendering of Antibody Drug Conjugate Molecules.

Small Molecule 145

Small Molecule Drugs Clinical Pharmacology Trials 145

thought leadership

SEPTEMBER 20, 2023

The FDA has recently issued this draft guidance to address clinical pharmacology considerations for peptide drug products. Since these products share specific aspects of biologics and small molecule drugs, this new guidance provides specific recommendations to address the special characteristics of these drugs.

Clinical Pharmacology 49

Clinical Pharmacology Production Small Molecule Drugs 49

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. food effect, smoking, and drug-drug interactions) on drug exposure and response.

Clinical Pharmacology 52

Clinical Pharmacology Drug Development Pharmacokinetics Drugs 52

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Additionally, this approach is generally no longer applicable to new treatments that are more targeted in their effects, such as immunotherapies and targeted small molecule therapies.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 40

Science FDA Trials Clinical Pharmacology 40

Agency IQ

DECEMBER 11, 2023

Previously, burdensome side effects may have been written off as a necessary part of treatment and benefits measured in additional weeks or months of survival time; today, though, patients, clinicians, and regulators expect more.

FDA 40

FDA Science Clinical Trials Trials 40