A Review of Current Methods for Food Effect Prediction During Drug Development
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FOOD FACTORS: MOLECULAR TARGETS, MECHANISMS, PHARMACOLOGY AND IN VIVO EFFICACY (D-X HOU, SECTION EDITOR)
A Review of Current Methods for Food Effect Prediction During Drug Development Tao Zhang 1 & Emily Wells 1
# Springer Nature Switzerland AG 2020
Abstract Ingestion of oral dosage forms with food can drastically change drug pharmacokinetic parameters to consumption in fasted state. Accurate prediction of food effect (FE) is an important focus during drug development, as well as a requirement for drug approval by the Food and Drug Administration. FE can significantly restrict the clinical usefulness of drugs and is a principal parameter that must be considered early in drug development. Several approaches are available to predict FE in the human, including cell culture models, a variety of small and large animal models, and, more recently, physiologically based pharmacokinetic computerized models that incorporate biorelevant drug physicochemical properties. Each has its own advantages and disadvantages. While many methods are available to study FE, not all of these methods are applicable, efficient, consistent, financially feasible, or reasonable for every drug or drug formulation. Most importantly, different models may offer different applicability in accurately predicting FE in human species. Drug development is a long and often expensive process. Understanding of and access to an appropriate, reproducible, frugal means of FE assessment is vital in the field of drug development in order to ensure the development of a safe and effective drug. The following review delineates the advantages and disadvantages of a variety of preclinical FE study methods. While no single approach is good enough to give completely reliable predictions, a combination of in vitro, in vivo, and in silico approach may be advantageous to predict FE. Keywords Food effect . Oral drug delivery . Pharmacokinetics . Biopharmaceutics Classification System
Introduction Oral drug delivery is a convenient and common method to administer drugs. For many reasons, including limitation of side effects, oral medications are often ingested with food. However, co-administration with food can affect drug efficacy and safety due to changes in pharmacokinetic (PK) parameters [1, 2]. This principle is referred to as food effect (FE) and is an important parameter to estimate in preclinical and clinical studies during the drug development process. This article is part of the Topical Collection on Food Factors: Molecular targets, mechanisms, pharmacology and in vivo efficacy * Tao Zhang [email protected] Emily Wells [email protected] 1
Husson University School of Pharmacy, Bangor, ME 04401, USA
The United States Food and Drug Administration (FDA) has specific requirements for these studies. Single-dose PK studies are often used to investigate exposure and absorption rate and extent [1, 2]. PK changes may cause clinical safety risks or treatment failure [1, 3]. Alternatively, food may not strongly affect the absorption or be clinically relevant at all [4, 5
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