Simulations Plus

Model Master Files (MMFs) offer a much needed approach to integrating computational modelling into drug development and regulatory frameworks, supporting the growth of quantitative medicine.

Drug-induced liver injury (DILI) is rare in clinical practice but when it occurs it can lead to acute liver failure and death. Drug developers and regulators undertake a series of steps to identify the DILI potential of a medication before it is approved for marketing.

The cytochrome P450 enzyme 3A4 (CYP3A4) mediates numerous drug-drug interactions (DDIs) by inducing the metabolism of co-administered drugs, which can result in reduced therapeutic efficacy or increased toxicity.

Levornidazole, a nitroimidazole compound, has been linked to hepatotoxic adverse effects in clinical settings.

We investigated the experimental solubility of tofacitinib citrate (TNF) in HSPiP predicted mono solvents at varied temperature points, followed by validation with various models (computational and thermodynamic) and GastroPlus based predicted in-vivo performance in individuals (adult humans).

Oxcarbazepine (OXC) has been approved as monotherapy or adjunctive therapy for paediatric partial seizures.

Amorphous solid dispersion (ASD) is one of the most important enabling formulation technologies for the development of poorly soluble drugs.

The perioperative period, encompassing preoperative, intraoperative, and postoperative phases, is crucial for comprehensive patient care.

Obesity poses a significant global health challenge, necessitating the search for novel therapeutic agents to address this epidemic.

Acetaminophen (APAP) has been formulated as immediate-, modified-, and extended-release tablets (APAP-IR, -MR, and -ER, respectively).

Diabetes mellitus is a long-term metabolic disorder characterized by persistent hyperglycemia, which can lead to various health problem if left untreated.

Neurotransmitters (NTs) mediate trans-synaptic signaling, and disturbances in their levels are linked to aging and brain disorders.

Mental illnesses put a tremendous burden on afflicted individuals and society.

The objective of this study is to address the unanswered question whether sustained supersaturation generated from amorphous solid dispersions (ASDs) formulated in insoluble hydrogel carriers will result in better bioavailability over that of spring-and-parachute type of dissolution profiles of ASDs formulated in water-soluble carriers

The protein kinase NUAK1 has been implicated in various biological functions including cell adhesion, migration and proliferation.

Selecting the development form of an active pharmaceutical ingredient (API) in drug development is key to determining the final performance of the drug substance and drug product.

The landscape of scientific research in Latin America (LA), particularly in the realms of the Physiologically Based Pharmacokinetic (PBPK) and Physiologically Based Biopharmaceutic models (PBPM), is a mosaic of varied contributions, collaborations, and specializations.

The pharmacokinetics of renally eliminated antibiotics can be influenced by changes associated with renal function and development in a growing subject. Little is known about the effects of renal insufficiency on the pharmacokinetics of meropenem in pediatric subjects.

 To determine if higher serum exposure during subcutaneous (SC) abatacept treatment was associated with an increased infection risk in adult patients with early rheumatoid arthritis (RA).

HIV-1, or Human Immunodeficiency Virus type 1, is a global pandemic that affects millions of individuals worldwide.