Related Experiment Video
Updated: Sep 6, 2025
08:31
Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
Published on: December 1, 2020
5.1K
Early Feasibility Assessment: A Method for Accurately Predicting Biotherapeutic Dosing to Inform Early Drug Discovery
Diana H Marcantonio1, Andrew Matteson1, Marc Presler1
1Applied BioMath, LLC, Concord, MA, United States.
Frontiers in Pharmacology
|June 27, 2022
Summary
Early Feasibility Assessment (EFA) uses early drug discovery data to predict effective doses. This model-informed approach accurately forecasts clinical doses for biotherapeutics, aiding novel therapeutic development.
Area of Science:
- Pharmacology
- Drug Development
- Biotherapeutics
Background:
- Model-informed drug discovery and development (MID3) is valuable but challenging in early stages due to limited pharmacokinetic (PK) and pharmacodynamic (PD) data.
- Prioritizing targets and defining optimal drug properties requires robust early-stage predictive models.
Purpose of the Study:
- To introduce and validate Early Feasibility Assessment (EFA) as a method for predicting effective doses in early drug discovery.
- To demonstrate the utility of EFA in making accurate dose predictions for biotherapeutics.
Main Methods:
- Development of mechanistic PKPD models based on first principles.
- Parameterization of models using data readily available in early drug discovery.
- Validation of EFA predictions against clinical effective doses of nine approved biotherapeutics.
Main Results:
- EFA accurately predicted clinical effective doses for nine approved biotherapeutics.
- The approach shows potential for application to novel therapeutics.
Conclusions:
- Early Feasibility Assessment (EFA) is a viable method for predicting effective doses early in the drug discovery process.
- EFA can significantly impact early decision-making for novel therapeutic development by providing reliable dose predictions.
More Related Videos
Related Concept Videos
01:26Drug Discovery: Overview
8.7K
Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
8.7K
01:28Preclinical Development: Overview
4.8K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
4.8K
01:16Bioequivalence: Overview
1.2K
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
1.2K
01:26Pharmacokinetic Models: Comparison and Selection Criterion
140
Physiological and compartmental models are valuable tools used in studying biological systems. These models rely on differential equations to maintain mass balance within the system, ensuring an accurate representation of the dynamic processes at play.
Physiological models take a detailed approach by considering specific molecular processes. They can predict drug distribution, metabolism, and elimination changes, providing a comprehensive understanding of how drugs interact with the body.
Physiological models take a detailed approach by considering specific molecular processes. They can predict drug distribution, metabolism, and elimination changes, providing a comprehensive understanding of how drugs interact with the body.
140
01:13Bioavailability: Overview
3.1K
Bioavailability refers to the proportion of an unaltered drug that, after administration, enters the systemic circulation and can be distributed to the desired action site. Factors such as gastrointestinal (GI) absorption and liver biotransformation influence the bioavailability of a drug when it is administered orally. When a drug is administered intravenously, it enters the systemic circulation directly; by definition, its bioavailability is assumed to be 100%. The bioavailability of an...
3.1K
01:13Physiological Pharmacokinetic Models: Assumption with Protein Binding
90
Physiological models with protein binding in pharmacokinetics offer a sophisticated approach to understanding drug disposition. These models consider drug-protein interactions, enabling them to effectively predict drug concentrations in different organs and tissues. This precision aids in accurate drug dosing, providing a significant advantage over conventional models. A key process within these models is equilibration, which ensures that drug concentrations achieve a steady state within the...
90