[From research to practice: clinical phases for drug development]
Jessie Nallely Zurita-Cruz1, Lourdes Barbosa-Cortés, Miguel Ángel Villasís-Keever
1Instituto Mexicano del Seguro Social, Centro Médico Nacional Siglo XXI, Hospital de Pediatría, Ciudad de México, México. villasis@gmail.com.
Revista Alergia Mexico (Tecamachalco, Puebla, Mexico : 1993)
|June 15, 2019
Summary
This study outlines the four clinical trial phases (I-IV) essential for drug development, assessing pharmacokinetics, safety, and efficacy. It also details modifications made to expedite the drug approval process for patient access.
Area of Science:
- Pharmacology
- Clinical Research
- Drug Development
Background:
- Clinical trials are crucial for evaluating new drugs' pharmacokinetics, pharmacodynamics, efficacy, and safety.
- The established model for drug development involves sequential clinical phases (I-IV) following preclinical (cellular and animal) studies.
Purpose of the Study:
- To synthesize the general characteristics of each clinical trial phase.
- To describe modifications implemented over time to accelerate drug availability.
Main Methods:
- Review and synthesis of existing knowledge on clinical trial phases.
- Analysis of historical modifications to the drug development process.
Main Results:
- Detailed overview of the distinct objectives and methodologies of Phases I, II, III, and IV.
- Identification of procedural adjustments aimed at streamlining the path from preclinical research to market approval.
Conclusions:
- The traditional phased approach to clinical trials remains fundamental.
- Adaptations in clinical trial design and execution have been made to expedite the delivery of novel therapeutics to patients.
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