Biomaterial Database

Mechanistic modeling of generic orally inhaled drug products: A workshop summary report. 2023

Ross L Walenga, and Clare Butler, and Brent A Craven, and P Worth Longest, and Raja Mohamed, and Bryan Newman, and Bo Olsson, and Günther Hochhaus, and Bing V Li, and Markham C Luke, and Liang Zhao, and Andrzej Przekwas, and Robert Lionberger

Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

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. This review summarizes the presentations and panel discussion that comprised a workshop session concentrated on the use of in silico models to predict various outcomes following orally inhaled drug product administration, including the status of such models and how model credibility may be effectively established.

UI	MeSH Term	Description	Entries
D003198	Computer Simulation	Computer-based representation of physical systems and phenomena such as chemical processes.	Computational Modeling,Computational Modelling,Computer Models,In silico Modeling,In silico Models,In silico Simulation,Models, Computer,Computerized Models,Computer Model,Computer Simulations,Computerized Model,In silico Model,Model, Computer,Model, Computerized,Model, In silico,Modeling, Computational,Modeling, In silico,Modelling, Computational,Simulation, Computer,Simulation, In silico,Simulations, Computer
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000280	Administration, Inhalation	The administration of drugs by the respiratory route. It includes insufflation into the respiratory tract.	Drug Administration, Inhalation,Drug Administration, Respiratory,Drug Aerosol Therapy,Inhalation Drug Administration,Inhalation of Drugs,Respiratory Drug Administration,Aerosol Drug Therapy,Aerosol Therapy, Drug,Drug Therapy, Aerosol,Inhalation Administration,Administration, Inhalation Drug,Administration, Respiratory Drug,Therapy, Aerosol Drug,Therapy, Drug Aerosol
D013810	Therapeutic Equivalency	The relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease.	Bioequivalence,Clinical Equivalency,Equivalency, Therapeutic,Generic Equivalency,Clinical Equivalencies,Equivalencies, Clinical,Equivalencies, Therapeutic,Equivalency, Clinical,Therapeutic Equivalencies,Bioequivalences,Equivalencies, Generic,Equivalency, Generic,Generic Equivalencies
D016568	Drugs, Generic	Drugs whose drug name is not protected by a trademark. They may be manufactured by several companies.	Drugs, Nonproprietary,Generic Drug,Generic Drugs,Drug, Generic,Nonproprietary Drugs
D058028	Research Report	Detailed account or statement or formal record of data resulting from empirical inquiry.	Report,Field Report,Investigative Report,Progress Report,Reports,Summary Report,Field Reports,Investigative Reports,Progress Reports,Report, Field,Report, Investigative,Report, Progress,Report, Summary,Reports, Field,Reports, Investigative,Reports, Progress,Reports, Summary,Research Reports,Summary Reports