Opportunities and Challenges Related to the Implementation of Model-Based Bioequivalence Criteria.
Clin Pharmacol Ther
; 105(2): 350-362, 2019 02.
Article
en En
| MEDLINE
| ID: mdl-30375647
The science of bioequivalence and biosimilarity has greatly evolved over the past 3 decades. Current methods for assessing bioequivalence mostly rely on noncompartmental pharmacokinetic (PK) analyses, which have proven to be reliable and robust for most products. However, the development of more complex products is forcing scientists and regulators to consider alternative approaches, including those derived from model-based population PK analyses. This article will examine the strengths and weaknesses of standard noncompartmental methods and compare them to model-based approaches, including a comparison of metrics associated with each method. Specific situations for which model-based approaches could prove to be more suitable will be presented, as well as potential bioequivalence metrics that could be considered for bioequivalence comparisons. The opportunities and challenges that are associated with these novel methods will also be discussed.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Equivalencia Terapéutica
/
Medicamentos Genéricos
/
Modelos Teóricos
Tipo de estudio:
Prognostic_studies
Límite:
Humans
Idioma:
En
Revista:
Clin Pharmacol Ther
Año:
2019
Tipo del documento:
Article
País de afiliación:
Canadá
Pais de publicación:
Estados Unidos