Results 21 to 30 of about 1,553,128 (257)

Physiologically‐based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1%

CPT: Pharmacometrics & Systems Pharmacology, 2021
Establishing bioequivalence (BE) for dermatological drug products by conducting comparative clinical end point studies can be costly and the studies may not be sufficiently sensitive to detect certain formulation differences.
Eleftheria Tsakalozou, Andrew Babiskin, Liang Zhao   +2 more
doaj   +1 more source

Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop

CPT: Pharmacometrics & Systems Pharmacology, 2023
On November 30, 2021, the US Food and Drug administration (FDA) and the Center for Research on Complex Generics (CRCG) hosted a virtual public workshop titled “Establishing the Suitability of Model‐Integrated Evidence (MIE) to Demonstrate Bioequivalence ...
Yuqing Gong, Peijue Zhang, Miyoung Yoon, Hao Zhu, Ameya Kohojkar, Andrew C. Hooker, Murray P. Ducharme, Jogarao Gobburu, Géraldine Cellière, Parmesh Gajjar, Bing V. Li, Raja Velagapudi, Yu Chung Tsang, Anna Schwendeman, James Polli, Lanyan Fang, Robert Lionberger, Liang Zhao   +17 more
doaj   +1 more source

Mechanistic modeling of generic orally inhaled drug products: A workshop summary report

CPT: Pharmacometrics & Systems Pharmacology, 2023
In silico mechanistic modeling approaches have been designed by various stakeholders with the goal of supporting development and approval of generic orally inhaled drug products in the United States.
Ross L. Walenga, Clare Butler, Brent A. Craven, P. Worth Longest, Raja Mohamed, Bryan Newman, Bo Olsson, Günther Hochhaus, Bing V. Li, Markham C. Luke, Liang Zhao, Andrzej Przekwas, Robert Lionberger   +12 more
doaj   +1 more source

Multi‐phase multi‐layer mechanistic dermal absorption (MPML MechDermA) model to predict local and systemic exposure of drug products applied on skin

CPT: Pharmacometrics & Systems Pharmacology, 2022
Physiologically‐based pharmacokinetic models combine knowledge about physiology, drug product properties, such as physicochemical parameters, absorption, distribution, metabolism, excretion characteristics, formulation attributes, and trial design or ...
Nikunjkumar Patel, James F. Clarke, Farzaneh Salem, Tariq Abdulla, Frederico Martins, Sumit Arora, Eleftheria Tsakalozou, Arran Hodgkinson, Omid Arjmandi‐Tash, Sinziana Cristea, Priyanka Ghosh, Khondoker Alam, Sam G. Raney, Masoud Jamei, Sebastian Polak   +14 more
doaj   +1 more source

Amphotericin B release rate is the link between drug status in the liposomal bilayer and toxicity

Asian Journal of Pharmaceutical Sciences, 2022
Amphotericin B (AmB) is an amphiphilic drug commonly formulated in liposomes and administered intravenously to treat systemic fungal infections. Recent studies on the liposomal drug product have shed light on the AmB aggregation status in the bilayer ...
Yuri Svirkin, Jaeweon Lee, Richard Marx, Seongkyu Yoon, Nelson Landrau, Md Abul Kaisar, Bin Qin, Jin H. Park, Khondoker Alam, Darby Kozak, Yan Wang, Xiaoming Xu, Jiwen Zheng, Benjamin Rivnay   +13 more
doaj   +1 more source

Logistic planning and drug formularies : considerations for clinically effective drug substitution [PDF]

, 2012
PhDDrug substitution is mainly economically not medically-driven; it can benefit healthcare services but does not directly benefit individual patients. Many healthcare providers have been promoting drug substitution in an attempt to contain their costs.
Alameri, Mubarak Nasser Mubarak Zain
core   +4 more sources

Do generic drugs cause hypersensitivity?

, 2022
International audienceGeneric drugs may differ from brand-name drugs in nature and quantity of excipients. Hypersensitivity to generic drugs is a subject of growing importance given their key role in healthcare spending policies, however, a review of ...
Tetart, Florence, Hervouët, Charles, Gonde, Henri   +2 more
core   +1 more source

Microbiome−host proteostasis crosstalk—An emerging perspective on mechanisms and interventions toward healthy longevity

FEBS Letters, EarlyView.
Proteostasis and the gut microbiota play a key role in shaping host physiology. Microbiota‐derived metabolites, vitamins, and RNA modulate host proteostasis. Findings from model systems, including C. elegans, indicate microbes can either stabilize or disrupt host proteostasis.
Abhishek Anil Dubey, Maria Ermolaeva
wiley   +1 more source

Key Factors for Improving Predictive Accuracy and Avoiding Overparameterization of the PBPK Absorption Model in Food Effect Studies of Weakly Basic Water-Insoluble Compounds in Immediate Release Formulations

Pharmaceutics
Background/Objectives: Physiologically based pharmacokinetic (PBPK) absorption models are instrumental for assessing drug absorption prior to clinical food effect studies, though discrepancies in predictive and actual outcomes are observed.
Miao Zhang, Shudong Zhang, Lin Wang, Zhe Zhang, Qin Hu, Dongyang Liu   +5 more
doaj   +1 more source

Association of partial systemic exposure and abuse potential for opioid analgesics with abuse deterrence labeling claims supporting product-specific guidance

EClinicalMedicine, 2021
Background: Over the past decade, U.S. FDA has approved 10 opioid analgesics in abuse-deterrent formulations (ADFs). ADFs are intended to reduce abuse of a prescription opioid through manipulation of the product to use one or more routes of abuse ...
Liang Zhao, Zhichuan Li, Lanyan Fang, Myong-Jin Kim, Srikanth C. Nallani, Chandrahas G. Sahajwalla, Silvia N. Calderon, Rigoberto A. Roca, Kairui Feng, Issam Zineh, Robert Lionberger   +10 more
doaj   +1 more source