Purpose and Scope of Clinical Research
Clinical research in industrial pharmacy aims to establish the safety and efficacy of new pharmaceuticals through a series of clinical trials (Phases I-IV) that progressively evaluate safety, dosage, effectiveness, and side effects.
Phases of Clinical Trials
Phase I
Participants: 20-100 healthy volunteers or patients.
Objective: Assess safety, tolerability, pharmacokinetics, and pharmacodynamics.
Phase II
Participants: 100-300 patients.
Objective: Evaluate drug efficacy, determine optimal dosing, and continue safety assessments.
Phase III
Participants: 1,000-3,000 patients.
Objective: Confirm efficacy, monitor side effects, and compare with standard treatments.
Phase IV (post-marketing)
Objective: Gather additional information on long-term risks, benefits, and optimal use.
Regulatory Compliance
Clinical trials must follow regulatory standards, such as Good Clinical Practice (GCP), which includes ethical considerations, informed consent, and rigorous methodologies.
Data Analysis and Reporting
Data from these trials are analyzed and compiled into reports for regulatory submissions, such as the New Drug Application (NDA).