Simulations Plus

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.

Clozapine is a potent serotonin receptor antagonist and commonly used for the treatment of Schizophrenia.

Drug discovery is inherently a multi-criteria optimization problem.

To evaluate the neuropharmacological profile of new spiro thiazepinone and thiazolidinone compounds in CD1 mice after a computer-aided virtual screening based on a GABA-A/BZD site.

Salbutamol, a short-acting β2-agonist used in asthma treatment, is available in multiple formulations, including inhalers, nebulizers, oral tablets, and intravenous, intramuscular, and subcutaneous routes.

Proteolysis-targeting chimeras (PROTACs) represent a promising class of drugs that can target disease-causing proteins more effectively than traditional small molecule inhibitors can, potentially revolutionizing drug discovery and treatment strategies.

The development of in silico approaches that can estimate the dermal absorption of chemicals exposed in practical conditions is highly anticipated. In the present study, an in silico model to estimate both the dermal absorption rate and dermal permeation profile was developed for the application of chemicals in finite dose conditions.

For many years, a method that allowed systemic toxicity safety assessments to be conducted without generating new animal test data, seemed out of reach.

A slight variation in in vivo exposure for tacrolimus extended-release (ER) capsules, which have a narrow therapeutic index (NTI), significantly affects the pharmacodynamics of the drug. Generic drug bioequivalence (BE) standards are stricter, necessitating accurate assessment of the rate and extent of drug release.

This review paper discusses the key aspects of ocular biopharmaceutics, with emphasis on the crucial role played by ocular compartmental modelling and simulation in deciphering physiological conditions related to various eye diseases.

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

This report summarizes the proceedings for Day 3 of the workshop titled “Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives”.

Spatholobi Caulis (SPC) is a medicinal plant that mainly grows in China and Southeast Asian countries and commonly used in clinics; the pharmacokinetic characteristics in humans need to be determined.

Mesalamine is a locally acting anti-inflammatory drug used to treat mild to moderate ulcerative colitis.

Carotenoids, potent antioxidants in fruits and vegetables, have recently garnered attention for their potential therapeutic effects against neurodegenerative diseases.

In recent years, hydrogels have emerged as a highly promising platform for the sustained delivery of therapeutic agents, addressing critical challenges in drug delivery systems, from controlled release to biocompatibility.