Smarter Clinical Development: How to Use QSP to Maximize the Value of GLP-1 Agonists

Smarter Clinical Development: How to Use QSP to Maximize the Value of GLP-1 Agonists

Authors: Siler SQ
Software: DILIsym®

As the market for GLP-1 agonists expands, biotech companies face both immense opportunity and fierce competition. To stand out in this evolving landscape and enhance the likelihood of acquisition or out-licensing, early-stage companies must develop a strategic, data-driven clinical development plan.

Phasing Out Animal Testing: Responding to FDA and EMA’s Strategic Shifts

Phasing Out Animal Testing: Responding to FDA and EMA’s Strategic Shifts

Both the U.S. Food and Drug Administration (FDA) (1) and the European Medicines Agency (EMA) (2) have articulated clear regulatory expectations for the implementation and advancement of non-animal methods, known as new approach methodologies (NAMs).

Role of Physiologically Based Biopharmaceutics Modeling in Predicting and Circumventing the Drug-Drug Interactions of Tyrosine Kinase Inhibitors with Acid-Reducing Agents

Role of Physiologically Based Biopharmaceutics Modeling in Predicting and Circumventing the Drug-Drug Interactions of Tyrosine Kinase Inhibitors with Acid-Reducing Agents

Publication: J Appl Pharm Sci
Software: GastroPlus®
Division: PBPK

Tyrosine kinase inhibitors (TKIs) are molecular targeting agents used to treat various types of cancer. During the treatment with TKIs, acid-reducing agents (ARAs) are prescribed to prevent gastric mucosal damage.

Evaluation of Violacein Metabolic Stability and Metabolite Identification in Human, Mouse, and Rat Liver Microsomes

Evaluation of Violacein Metabolic Stability and Metabolite Identification in Human, Mouse, and Rat Liver Microsomes

Publication: Pharmaceutics
Software: ADMET Predictor®
Division: Cheminformatics

Malaria significantly impacts the health of populations living in poverty and vulnerable conditions. Resistance to current antimalarial drugs remains a major challenge and highlights the urgent need for novel, effective, and safer therapies.

Utilizing Physiologically Based Pharmacokinetic Models to Support Rational Medication in Chinese Elderly Population

Utilizing Physiologically Based Pharmacokinetic Models to Support Rational Medication in Chinese Elderly Population

Authors: Wu X, Wang Z, Liu S, Wang H
Publication: Drug Des Devel Ther
Software: GastroPlus®
Division: PBPK

China is undergoing a pronounced shift towards an aging society, wherein the elderly constitute a prominent demographic relying significantly on medications.

Simulations Plus Supports New FDA Roadmap for Reducing Animal Testing in Preclinical Safety Studies

Simulations Plus Supports New FDA Roadmap for Reducing Animal Testing in Preclinical Safety Studies

Modeling and simulation will be a key component for shift to non-animal methodologies

Introducing NAMVantage(TM), a flagship package offering PBPK and QSP professional services and regulatory strategy combined with built-in coaching and training

From In Vivo Predictive Dissolution to Virtual Bioequivalence: A GastroPlus®-Driven Framework for Generic Candesartan Cilexetil Tablets

From In Vivo Predictive Dissolution to Virtual Bioequivalence: A GastroPlus®-Driven Framework for Generic Candesartan Cilexetil Tablets

Publication: Pharmaceuticals
Software: GastroPlus®
Division: PBPK

Candesartan cilexetil, a Biopharmaceutics Classification System (BCS) II prodrug, demonstrates compromised bioavailability attributable to its limited aqueous solubility coupled with P-glycoprotein (P-gp)-mediated efflux and hepatic first-pass metabolism, thereby introducing complexities in generic drug bioequivalence assessments.

Mode of Action Approach Supports a Lack of Carcinogenic Potential of Six Organic UV Filters

Mode of Action Approach Supports a Lack of Carcinogenic Potential of Six Organic UV Filters

Publication: Crit Rev Toxicol
Software: GastroPlus®
Division: PBPK

Ultraviolet (UV) filters, the active ingredients in sunscreens, have been used for several decades to reduce the risk of acute and chronic damage to the skin from solar UV radiation, which can lead to skin cancer.

Mode of Action Approach Supports a Lack of Carcinogenic Potential of Six Organic UV Filters

Mode of Action Approach Supports a Lack of Carcinogenic Potential of Six Organic UV Filters

Publication: Crit Rev Toxicol
Software: GastroPlus®
Division: PBPK

Ultraviolet (UV) filters, the active ingredients in sunscreens, have been used for several decades to reduce the risk of acute and chronic damage to the skin from solar UV radiation, which can lead to skin cancer.