Results 61 to 70 of about 1,092 (147)

Optimization of Sustained-release Diltiazem Formulations in Man by use of an In-vitro/In-vivo Correlation

, 1998
In-vitro/in-vivo correlations (IVIVC) are useful for predicting in-vivo results from in-vitro data. An IVIVC has been used to optimize a hydrocolloidal-based matrix tablet designed to be bioequivalent to an existing once-daily diltiazem HCl*** product ...
M Gebert, K Yu, D Wong, D R Friend, S A Altaf   +4 more
core   +1 more source

Impact of Mechanistic Modeling and Simulation Methodologies on Product‐Specific Guidance Development for Non‐Orally Administered Drug Products

CPT: Pharmacometrics &Systems Pharmacology, Volume 14, Issue 9, Page 1421-1430, September 2025.
ABSTRACT The U.S. Food and Drug Administration (FDA) publishes product‐specific guidances (PSGs), with bioequivalence (BE) recommendations for prospective generics. Developing BE recommendations for non‐orally administered drug products including long‐acting injectables (LAI), orally inhaled drug products, and drugs applied locally to the skin ...
Steven G. Chopski, Ross L. Walenga, Ming‐Liang Tan, Khondoker Alam, Andrew Babiskin, Lanyan Fang, Eleftheria Tsakalozou   +6 more
wiley   +1 more source

Application of in vitro – in vivo correlation as a predictive tool for bioequivalence of generic paracetamol immediate release oral tablets

, 2019
An in vitro – in vivo correlation (IVIVC) model can predict the bioavailability of some drug substances, and mitigate against the high cost of bioequivalence studies, long generic product development lead times, and the exposure of human subjects to drug
Kuria, K.A.M., Tirop, L.J., Atebe, R, Maru, S.M.   +3 more
core   +1 more source

Nanoparticle Therapeutics in Clinical Perspective: Classification, Marketed Products, and Regulatory Landscape

Small, Volume 21, Issue 29, July 24, 2025.
This review presents a detailed overview of clinically approved nanoparticle therapeutics, classifying them by type and discussing their unique advantages in drug delivery. It highlights regulatory challenges across global markets and emphasizes the need for adaptive approval pathways.
Nimeet Desai, Dhwani Rana, Mitali Patel, Neha Bajwa, Rajendra Prasad, Lalitkumar K. Vora   +5 more
wiley   +1 more source

Advancing Medical Applications of Cancer Nanotechnology: Highlighting Two Decades of the NCI'S Nanotechnology Characterization Laboratory Service to the Research Community

WIREs Nanomedicine and Nanobiotechnology, Volume 17, Issue 3, May/June 2025.
The field of cancer nanomedicine has seen tremendous advancements over the last two decades, not only in the nanotechnologies themselves, but in the applications and uses of these novel nanomaterials and the characterization techniques employed to better understand both their physicochemical and biological properties. AI, artificial intelligence; QSAR,
Rachael M. Crist, Yechezkel Barenholz, Ahuva Cern, Kate N. Clark, Pieter R. Cullis, Cheryl Dean, Neil Desai, Mauro Ferrari, Matthieu Germain, Carmen A. Giacomantonio, Emma Grabarnik, Piotr Grodzinski, Atara Hod, Barry E. Kennedy, Ruvanthi N. Kularatne, Glen S. Kwon, Emmanuel Loeb, Erin B. Noftall, Len Pagliaro, Morteza Rasoulianboroujeni, Alexander Roth, Darren Rowles, Kulbir Singh, Nicole F. Steinmetz, Zhanna Yehtina, Yao Zhang, Daniel Zilbersheid, Jeffrey D. Clogston, Stephan T. Stern, Marina A. Dobrovolskaia   +29 more
wiley   +1 more source

Translational Physiologically Based Pharmacokinetic Modeling to Predict Human Pulmonary Kinetics After Lung Delivery

CPT: Pharmacometrics &Systems Pharmacology, Volume 14, Issue 4, Page 796-806, April 2025.
ABSTRACT Predicting human lung exposure with reasonable certainty of orally inhaled drugs based on preclinical studies remains a challenge for drug development. We have developed a comprehensive physiologically based pharmacokinetic (PBPK) framework tailored for the pulmonary pharmacokinetic (PK) behavior in both humans and rats, aiming to bridge the ...
Haini Wen, Muhammad Waqas Sadiq, Lena E. Friberg, Elin M. Svensson   +3 more
wiley   +1 more source

Integrating Model‐Informed Drug Development With AI: A Synergistic Approach to Accelerating Pharmaceutical Innovation

Clinical and Translational Science, Volume 18, Issue 1, January 2025.
ABSTRACT The pharmaceutical industry constantly strives to improve drug development processes to reduce costs, increase efficiencies, and enhance therapeutic outcomes for patients. Model‐Informed Drug Development (MIDD) uses mathematical models to simulate intricate processes involved in drug absorption, distribution, metabolism, and excretion, as well
Karthik Raman, Rukmini Kumar, Cynthia J. Musante, Subha Madhavan   +3 more
wiley   +1 more source

In Vitro and In Vivo Correlation of BMP-2 Release Profiles from Complex Delivery Vehicles

, 2018
Local sustained delivery of bioactive molecules from biomaterials is a promising strategy to enhance bone regeneration. To optimize delivery vehicles for bone formation, the design characteristics are tailored with consequential effect on BMP-2 release ...
Orthopedie en neurochirurgie, dCSCA RMSC-1, Kempen, Diederik H R, Faculteit Diergeneeskunde, Olthof, Maurits Geert Laurent, Dhert, Wouter, Tryfonidou, Marianna A, Onderzoek, Dadsetan, Mahrokh, Yaszemski, Michael J, Lu, Lichun   +10 more
core   +1 more source

Inulin‐Lipid Core–Shell Microcapsules Target the Gut Microbiota and Mimic the Pharmaceutical Food Effect for Improved Oral Antipsychotic Delivery

Advanced Functional Materials, Volume 34, Issue 40, October 1, 2024.
A multifunctional oral drug delivery vehicle is engineered to overcome the multifaceted challenges of antipsychotic drugs, including their poor bioavailability and impact on the gut‐brain axis. Inulin‐lipid microcapsules facilitated an increase in lurasidone absorption by increasing drug solubility while targeting the gut microbiota increased microbial
Tahlia R. Meola, Aurelia Elz, Anthony Wignall, Kara Paxton, Alexander Hunter, Amin Ariaee, Srinivas Kamath, Stephanie E. Reuter, Clive A. Prestidge, Paul Joyce   +9 more
wiley   +1 more source

An investigation into the usefulness of generalized regression neural network analysis in the development of level A in vitro-in vivo correlation

, 2007
Quantitative correlations between in vivo and in vitro data (IVIVC) reduce the number of human in vivo studies, thus decreasing the overall time and expenses necessary for the development of optimal drug product formulation.
Parojčić, Jelena, Đurić, Zorica, Jovanović, Milica, Ibrić, Svetlana, Corrigan, Owen I.   +4 more
core   +1 more source