We focused to explore a suitable solvent for rifampicin (RIF) recommended for subcutaneous (sub-Q) delivery [ethylene glycol (EG), propylene glycol...
Extemporaneous Compounding and Physiological Modeling of Amlodipine/Valsartan Suspension
In case of absent liquid dosage form, crushing a tablet or dispersing a capsule would be the most convenient option for using these drugs in patients with dysphagia difficulties.
Next generation risk assessment of human exposure to anti-androgens using newly defined comparator compound values
Next Generation Risk Assessment (NGRA) can use the so-called Dietary Comparator Ratio (DCR) to evaluate the safety of a defined exposure...
In vitro and in vivo correlation for lipid-based formulations: Current status and future perspectives
Lipid-based formulations (LBFs) have demonstrated a great potential in enhancing the oral absorption of poorly water-soluble drugs.
A comprehensive review of integrative pharmacology-based investigation: A paradigm shift in traditional Chinese medicine
Over the past decade, traditional Chinese medicine (TCM) has widely embraced systems biology and its various data integration approaches to promote its modernization.
Relationship of the Calcitonin Gene-Related Peptide Monoclonal Antibody Galcanezumab Pharmacokinetics and Capsaicin-Induced Dermal Blood Flow in Healthy Subjects
Galcanezumab, a humanized monoclonal antibody targeting calcitonin gene-related peptide, was recently approved for...
AAPS Webinar: Translating manufacturing variants from in vitro to the clinic. Opportunities and gaps for IR formulations with additional IVIVC ‘Safe Space’ applications
Development of an in vitro/in vivo correlation (IVIVC) can be most challenging for immediate release (IR) products
Simulations Plus Forms Scientific Advisory Board for RENAsym Consortium
RENAsym SAB to Provide Insights and Guidance for Development of Kidney Injury Software
March 2021 News/Events
2021 SLP MIDD+ Scientific Conference Wrap Up Report
A Survey of the Regulatory Requirements for the Waiver of In Vivo Bioequivalence Studies of Generic Products in Certain Dosage Forms by Participating Regulators and Organisations of the International Pharmaceutical Regulators Programme
The requirements to waive in vivo bioequivalence studies for immediate release solid oral dosage forms based on the Biopharmaceutics Classifications System (BCS) are well known, and biowaivers[1] for other types of oral dosage forms based on pre-defined criteria may also be acceptable.
Physiologically Based Biopharmaceutics Modeling of Regional and Colon Absorption in Dogs
Colon absorption is a key determinant for the successful development of modified-release (MR) formulations, and the risk that colon absorption may limit the in vivo performance...
An IPRP survey of the regulatory requirements for the waiver of in vivo bioequivalence studies of generic medicinal products in certain dosage forms
The requirements to waive in vivo bioequivalence studies for immediate release solid oraldosage forms based on the Biopharmaceutics Classifications System (BCS) are well known, and biowaiversafor other types of oral dosage forms based on pre-defined criteria may also be acceptable.
Retrospective Analysis Using Pharmacokinetic/Pharmacodynamic Modeling and Simulation Offers Improvements in Efficiency of the Design of Volunteer Infection Studies for Antimalarial Drug Development
Volunteer infection studies using the induced blood stage malaria (IBSM) model have been shown to facilitate antimalarial...
Simulations Plus Hosts the Inaugural 2021 MIDD+ Scientific Conference with over 50 Model-Informed Drug Development Sessions
Speakers from Academia, Large Pharma Collaborations and Regulatory Agencies shared their real-world impact using modeling & simulation technology
New Library of Tumor Growth Inhibition Models in Monolix
Presentation of the models in the TGI library available in Monolix and Simulx
Neutralization of European, South African, and United States SARS-CoV-2 mutants by a human antibody and antibody domains
Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) transmission with several emerging variants remain uncontrolled in many countries, indicating the pandemic remains severe.
Leveraging Oral Drug Development to a Next Level: Impact of the IMI-Funded OrBiTo Project on Patient Healthcare
A thorough understanding of the behavior of drug formulations in the human gastrointestinal (GI) tract is essential when working in the field of oral drug development in a pharmaceutical company.
2021 MIDD+ Welcome and Introduction
Evolving relationship between M&S and pharma R&D
Introduction to Phase III track with Beth Ludwig
Beth Ludwig, Associate Vice President, Quantitative Clinical Pharmacology, gives a brief introduction to the application of Modeling & Simulation in Phase 3 - questions to be addressed, speakers, and presentations.