This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms.
Development of Physiologically Based Pharmacokinetic Model for Pregabalin to Predict the Pharmacokinetics in Pediatric Patients with Renal Impairment and Adjust Dosage Regimens
Pregabalin (PGB) is widely used clinically; however, its pharmacokinetics (PK) has not been studied in pediatric patients with renal impairment (RI).
PBPK Modeling and Simulation of Antibiotics Amikacin, Gentamicin, Tobramycin, and Vancomycin Used in Hospital Practice
The importance of closely observing patients receiving antibiotic therapy, performing therapeutic drug monitoring (TDM), and regularly adjusting dosing regimens has been extensively demonstrated.
Animal metrics: Tracking contributions of new approach methods to reduced animal use
Many companies and global regulatory programs have expressed the intent to move away from in vivo animal testing to new approach methods (NAMs) as part of product safety assessments.
Optimization of Personalized Amlodipine Dosing Strategies for Children Based on Pharmacokinetic Data from Chinese Male Adults and PBPK Modeling
For children, a special population who are continuously developing, a reasonable dosing strategy is the key to clinical therapy.
Predicting pharmacokinetics of multisource acyclovir oral products through physiologically based biopharmaceutics modeling
Highly variable disposition after oral ingestion of acyclovir has been reported, although little is known regarding the underlying mechanisms.
Physiologically Based Biopharmaceutics Modeling to Demonstrate Virtual Bioequivalence and Bioequivalence Safe-Space for Ribociclib which has Permeation Rate-Controlled Absorption
A physiologically based biopharmaceutics model (PBBM) was developed to support formulation development of ribociclib, an orally bioavailable selective CDK4/6 inhibitor.
Deep eutectic liquid as transdermal delivery vehicle of Risperidone
The work outlined herein describes an evaluation of a green solvent working as a drug solubility and penetration enhancer made up of a deep eutectic system (DES) composed of menthol (MN) and capric acid (CA).
A phase I dose-escalation study of oxaliplatin delivered via a laparoscopic approach using pressurised intraperitoneal aerosol chemotherapy for advanced peritoneal metastases of gastrointestinal tract cancers
The objectives were to define the maximum tolerated dose (MTD), safety profile and pharmacokinetics (PKs) of intraperitoneal oxaliplatin delivered by pressurized intraperitoneal...
Development of physiologically-based pharmacokinetic models for standard of care and newer tuberculosis drugs
Tuberculosis (TB) remains a global health problem and there is an ongoing effort to develop more effective therapies and new combination regimes that can reduce duration of treatment.
Pharmacokinetics of Baclofen in a Full-Term Newborn after Intrauterine Exposure: A Case Report
Intrauterine exposure to baclofen can lead to syndrome of withdrawal during the first days of the newborn.
A new phenothiazine derivate is active against Clostridioides difficile and shows low cytotoxicity
The rapid evolution of antibiotic resistance in Clostridioides difficile and the consequent effects on prevention and treatment of C.
Slower degradation rate of cytarabine in blood samples from acute myeloid leukemia by comparison with control samples
Cytarabine, a key chemotherapy agent for acute myeloid leukemia (AML) treatment, is deaminated into inactive uracil-arabinoside by cytidine deaminase.
Dose Selection for Fremanezumab (AJOVY) Phase 3 Pediatric Migraine Studies Using Pharmacokinetic Data From a Pediatric Phase 1 Study and a Population Pharmacokinetic Modeling and Simulation Approach
Potential fremanezumab doses for pediatric patients were evaluated using pharmacokinetic modeling and
Pharmacokinetics of Pantoprazole and Pantoprazole Sulfone in Goats After Intravenous Administration: A Preliminary Report
Ruminant species are at risk of developing abomasal ulceration, but there is a lack of pharmacokinetic data for anti-ulcer therapies, such as the proton pump inhibitor pantoprazole, in...
Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms Using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies
For oral drug products, in vitro dissolution is the most used surrogate of in vivo dissolution and absorption.
Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies
For oral drug products, in vitro dissolution is the most used surrogate of in vivo dissolution and absorption.
Integrated Testing Strategy for the Safety of Botanical Ingredients: A Case Study with German Chamomile Constituents
Introduction: chamomile is a botanical ingredient commonly used in cosmetics, thus determination of skin sensitization effects of German chamomile constituents is critical for the...
Comparison of in vitro, in vivo, and in silico bioavailability results of different prednisone tablet formulations to assess the feasibility of possible biowaiver
The immediate-release solid oral products containing very soluble and permeable drugs are candidates for the biowaiver process.
Physiologically Based Pharmacokinetic/Pharmacodynamic Modeling to Evaluate the Absorption of Midazolam Rectal Gel
We aimed to 1) develop physiologically based pharmacokinetic/pharmacodynamic (PBPK/PD) models of a novel midazolam rectal gel in healthy adults, 2) assess the contribution of different physiologically relevant...