Pharmacology

  1. Drug Development and Regulation
    1. Drug Discovery
      1. Target Identification
        1. Disease Understanding
          1. Target Validation
            1. Druggability Assessment
            2. Lead Discovery
              1. Natural Product Screening
                1. High-Throughput Screening
                  1. Virtual Screening
                    1. Fragment-Based Drug Design
                    2. Lead Optimization
                      1. Structure-Activity Relationships
                        1. ADMET Optimization
                          1. Selectivity Improvement
                          2. Candidate Selection
                            1. Preclinical Profiling
                              1. Developability Assessment
                            2. Preclinical Development
                              1. In Vitro Studies
                                1. Pharmacological Profiling
                                  1. ADMET Studies
                                    1. Toxicity Screening
                                    2. In Vivo Animal Studies
                                      1. Pharmacokinetic Studies
                                        1. Efficacy Studies
                                          1. Safety Studies
                                            1. Acute Toxicity
                                              1. Repeat-Dose Toxicity
                                                1. Genotoxicity
                                                  1. Carcinogenicity
                                                    1. Reproductive Toxicity
                                                  2. Regulatory Toxicology
                                                    1. Good Laboratory Practice
                                                      1. Study Design Requirements
                                                        1. Species Selection
                                                      2. Clinical Development
                                                        1. Regulatory Framework
                                                          1. Investigational New Drug Application
                                                            1. Clinical Trial Protocols
                                                              1. Ethics Committees
                                                              2. Phase I Clinical Trials
                                                                1. First-in-Human Studies
                                                                  1. Dose Escalation Studies
                                                                    1. Pharmacokinetic Studies
                                                                      1. Safety Assessment
                                                                      2. Phase II Clinical Trials
                                                                        1. Proof-of-Concept Studies
                                                                          1. Dose-Finding Studies
                                                                            1. Efficacy Evaluation
                                                                              1. Patient Population Definition
                                                                              2. Phase III Clinical Trials
                                                                                1. Pivotal Efficacy Trials
                                                                                  1. Large-Scale Safety Studies
                                                                                    1. Comparative Effectiveness
                                                                                      1. Registration Studies
                                                                                      2. New Drug Application
                                                                                        1. Regulatory Submission
                                                                                          1. Review Process
                                                                                            1. Approval Decision
                                                                                            2. Phase IV Studies
                                                                                              1. Post-Marketing Surveillance
                                                                                                1. Pharmacovigilance
                                                                                                  1. Risk Evaluation and Mitigation
                                                                                                2. Regulatory Agencies
                                                                                                  1. Food and Drug Administration
                                                                                                    1. Organization and Function
                                                                                                      1. Approval Pathways
                                                                                                        1. Special Programs
                                                                                                        2. European Medicines Agency
                                                                                                          1. Centralized Procedure
                                                                                                            1. Mutual Recognition
                                                                                                            2. International Harmonization
                                                                                                              1. ICH Guidelines
                                                                                                                1. Global Drug Development
                                                                                                              2. Drug Classification and Scheduling
                                                                                                                1. Controlled Substances
                                                                                                                  1. Schedule Classifications
                                                                                                                    1. Prescription Requirements
                                                                                                                      1. Abuse Potential Assessment
                                                                                                                      2. Over-the-Counter Drugs
                                                                                                                        1. OTC Monographs
                                                                                                                          1. Switch from Prescription
                                                                                                                          2. Orphan Drugs
                                                                                                                            1. Designation Criteria
                                                                                                                              1. Development Incentives

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                                                                                                                          3. Pharmacodynamics

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                                                                                                                          5. Adverse Drug Reactions and Drug Safety