Drug Target Review

MARCH 24, 2025

Promising areas for AI implementation When discussing the most transformative AI applications in drug discovery, Sujeegar identifies a particularly ambitious goal: developing AI models that can simulate human pharmacokinetics and pharmacodynamics (PK/PD) using only preliminary laboratory data.

Clinical Trials

Chemical Biology and Drug Design

JULY 1, 2025

Additionally, molecular docking was performed against 22 MTB protein targets to explore possible mechanisms of action, and ADMET predictions were used to determine pharmacokinetic and pharmacodynamic suitability.

Pharmacokinetics

Drug Target Review

APRIL 7, 2025

As pharmacological indicators, biomarkers overcome the static nature of traditional in vitro cellular studies by providing more dynamic models of pharmacokinetic processes that reflect active biological mechanisms. Trial design and statistical methods are also key to determining the utility and validity of biomarkers.

Clinical Development

Drug Patent Watch

DECEMBER 30, 2024

Key Requirements for Generic Drug Approval Bioequivalence Studies : The PMDA requires bioequivalence studies to ensure that the generic drug is equivalent to the RLD in terms of its pharmacokinetic and pharmacodynamic properties.

Drug Development

Drug Target Review

JUNE 6, 2025

And in the small molecule space, it’s about overcoming pharmacokinetic factors and formulation issues.” Greally explains that this iterative approach allows for more rigorous evaluation of ADC candidates, particularly in relation to pharmacokinetics and in vivo performance.

Small Molecule

New Drug Approvals

JULY 5, 2025

Promising Results: Preliminary results from clinical trials have shown promising antitumor efficacy and favorable pharmacokinetic properties for palazestrant. Combination Therapy: Palazestrant is being evaluated in combination with other drugs like CDK4/6 inhibitors (e.g., ribociclib).

Small Molecule

Chemical Biology and Drug Design

DECEMBER 5, 2024

The synthesized molecules were assessed for their pharmacological potential via cell viability, drug metabolism and pharmacokinetics (DMPK), and MERTK inhibition studies corroborated by in silico studies. The molecules were synthesized via a multi-step synthetic approach.

Immune Response

Drug Target Review

DECEMBER 11, 2024

For these studies, a comprehensive approach to drug metabolism and pharmacokinetics (DMPK), along with immunogenicity is essential, drawing on expertise from multiple disciplines. Special attention is required when dealing with antibody-based therapeutics due to their high susceptibility to biotransformation.

International

Drug Target Review

JULY 21, 2025

A board-certified toxicologist, she specialises in designing and managing nonclinical programmes across various modalities, including toxicology, pharmacokinetics, ADME and safety pharmacology. Her expertise spans CRO oversight, regulatory strategy and CTD-compliant submissions for INDs and NDAs.

Drug Development

Collaborative Drug

JULY 28, 2025

Some of the most recent enhancements to the CDD Vault Curves add-on include the Pharmacokinetic (PK) IV and Oral curve fits. If you are not yet subscribed to Curves, please contact your CDD Account Manager, or CDD Support , to discuss enabling these features in your Vault.

Testimonials

Broad Institute

OCTOBER 29, 2024

So the team turned their attention to optimizing the pharmacokinetic profile of BRD-810 to preserve its ability to kill tumor cells without negatively affecting heart cells.

Drugs

The Pharma Data

JUNE 25, 2025

Phase 1 Study Overview The Phase 1 clinical program was structured as a single ascending dose study to assess safety, tolerability, and pharmacokinetics of salanersen. The study included two parts: Part A : A randomized, placebo-controlled segment in healthy adult male volunteers.

Therapies

The Pharma Data

JUNE 22, 2025

The study marks a significant step forward in the treatment landscape for haemophilia A, demonstrating not only clinical safety and pharmacokinetic stability, but also strong patient preference for the Mim8 pen-injector delivery system.

Pharmacokinetics

Drug Target Review

JUNE 16, 2025

Unlike traditional pharmacokinetic (PK) studies that rely on plasma measurements alone, MSI, when combined with traditional histology, enables spatial mapping of drug distribution, metabolism and target engagement.

Drugs

Drug Target Review

JUNE 19, 2025

South Rampart Pharma has completed its Phase 1 clinical trial, demonstrating strong safety, tolerability and pharmacokinetics. From bench to bedside: what is next? SRP-001 has already moved beyond the laboratory.

Clinical Trials

The Pharma Data

JUNE 27, 2025

The GEMZ study is a randomized, double-blind, placebo-controlled, fixed-dose, multi-center clinical trial designed to assess the safety, efficacy, and pharmacokinetics of fenfluramine in children and adults aged 1 to 35 years diagnosed with CDD who experience uncontrolled seizures.

Trials

The Pharma Data

JUNE 23, 2025

In tandem with the Phase 2 results, Amgen also shared detailed data from its Phase 1 Pharmacokinetics Low Dose Initiation (PK-LDI) study. This study explored the effects of beginning treatment with lower starting doses of MariTide to improve tolerability while maintaining clinical benefit.

Trials

Covalent Modifiers

NOVEMBER 22, 2024

4c01541 Covalent drugs provide pharmacodynamic and pharmacokinetic advantages over reversible agents. Atienza, Kendall Muzzarelli, Zahra Assar, and Maurizio Pellecchia Journal of Medicinal Chemistry 2024 DOI: 10.1021/acs.jmedchem.4c01541

Pharmacokinetics

Drug Target Review

DECEMBER 4, 2024

What are the primary considerations in optimising the pharmacokinetics (PK) and biodistribution of MC4R-specific nanobodies in preclinical obesity models, and how does Confo Therapeutics plan to address challenges related to blood-brain barrier penetration?

Small Molecule

Alta Sciences

DECEMBER 31, 2024

The issue also features a drug-drug interaction case study, in which the effects of two doses of a sponsors investigational product on the pharmacokinetics of multiple oral doses of clopidogrel, and a single dose of warfarin in healthy adult subjects were evaluated. The Altascientist, Issue 7, pg. The Altascientist, Issue 7, pg.

Therapies

Drug Target Review

JULY 7, 2025

Their unique suitability has made them valuable for evaluating pharmacokinetics, toxicology and safety in drug candidates before human clinical trials.

Drug Research

DrugBank

JUNE 18, 2025

Regulatory agencies require pharmaceutical companies to submit preclinical and clinical trial data covering toxicology, pharmacokinetics, pharmacodynamics, and long-term safety monitoring. These submissions contain comprehensive data on clinical efficacy, pharmacokinetics, pharmacodynamics, and risk-benefit assessments.

Drug Development

Alta Sciences

FEBRUARY 19, 2025

We use validated bioanalytical solutions using LC-MS, hybridization-based assays, and ligand-binding techniques to drive precise quantification, immunogenicity risk assessment, and informed dose selectioncritical for pharmacokinetics, biodistribution, and safety evaluations.

Drug Development

The Pharma Data

JUNE 11, 2025

Conducted in healthy adult volunteers, these studies were designed to evaluate the pharmacokinetics and establish bioequivalence between the new tablet and the original capsule form.

FDA Approval

The Pharma Data

JUNE 25, 2025

These studies demonstrated that the BRUKINSA tablet formulation is bioequivalent to the existing capsule form, confirming that patients switching between formulations can expect comparable pharmacokinetics and clinical outcomes.

Packaging

The Pharma Data

JULY 2, 2025

Promising Results from Phase 1b Trial The Phase 1b study was a multicenter, randomized, double-blind, placebo-controlled clinical trial specifically designed to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary efficacy of ARGX-119 in individuals with DOK7-related CMS.

Clinical Trials

New Drug Approvals

MAY 9, 2025

1] [8] Pharmacokinetics Elacestrant has an oral bioavailability of approximately 10%. [1] 2] [4] Pharmacology Pharmacodynamics Elacestrant is an antiestrogen that acts as an antagonist of estrogen receptors , specifically targeting the estrogen receptor alpha (ER), which is the biological target of endogenous estrogens like estradiol. [1]

FDA

New Drug Approvals

JULY 25, 2025

16] Population pharmacokinetics (PK) of vamorolone was shown to fit to a 1-compartment model with zero-order absorption, with both adult men and young boys showing dose-linearity of PK parameters for the doses examined, and no accumulation of the drug during daily dosing. . mg/kg/day suggesting benefit. [15] 17 (9): e1003222. PMC 7505441.

FDA

The Pharma Data

JUNE 9, 2025

This pharmacokinetic profile enables season-long protection with a single dose, aligning with the standard length of the RSV season in most regions. A unique feature of Beyfortus is its extended half-life of 71 days, making it the longest-acting monoclonal antibody available for RSV prevention.

Virus

Elrig

MARCH 25, 2025

Earlier in her career, she held several leadership roles within AstraZeneca, including Senior Director for Drug Metabolism & Pharmacokinetics and Director for Lead Optimisation & Enabling Technologies within medicinal chemistry.

RNA

New Drug Approvals

JULY 19, 2025

In a pharmacokinetic (PK) rat model, the exposure of active drug CZD after IV administration of the prodrug CZA was similar to or higher than that from the IV administration of CZD. CZA exhibits high aqueous solubility (>200 mg/mL) and good hydrolytic stability at media pH suitable for IV administration.

Clinical Trials

DrugBank

JULY 14, 2025

The complexity of pharmacokinetics and pharmacodynamics, coupled with the variability in patient populations, makes predicting and managing DDI a particularly challenging aspect of drug development.  The most clinically significant pharmacokinetic interactions are often those that influence drug metabolism.

Clinical Development

Conversations in Drug Development Trends

JANUARY 21, 2025

Bioanalysis during clinical development of a drug is an indispensable process where trials obtain critical data pertinent to pharmacokinetics (PK) and pharmacodynamics (PD) and as readouts that are crucial for assessing the safety and efficacy of the drugs.

Clinical Trials

New Drug Approvals

JUNE 11, 2025

J Clin Psychopharmacol. 1990 Jun;10(3 Suppl):6S-12S.

FDA

New Drug Approvals

JULY 2, 2025

External links What to Know About Eli Lilly’s Daily Pill for Weight Loss , The New York Times, April 17, 2025 Above: molecular structure of orforglipron Below: 3D representation of an orforglipron molecule Clinical data Other names LY-3502970 Routes of administration Oral ATC code None Pharmacokinetic data Elimination half-life 29–49 hours Identifiers (..)

Small Molecule

Covalent Modifiers

JULY 8, 2025

Subsequent optimization efforts yielded S-892216, which combined a favorable pharmacokinetic profile and high off-target selectivity. Structure-based design of a covalent modifier for compound 1 revealed that introducing a nitrile warhead increased 3CLpro inhibition activity by 180-fold.

Pharmacokinetics

Drug Target Review

MARCH 17, 2025

The drug’s pharmacokinetics (PK) and pharmacodynamics (PD) are closely linked. 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.

Treatment