PHARMACEUTICAL DEVELOPMENT PROJECT CHECKLIST TEMPLATE

Created by ChecklistGuro (https://checklistguro.com)

--- TARGET IDENTIFICATION & VALIDATION ---
[ ] Initial Disease Area Selection Rationale
[ ] Disease Prevalence Data Source (WHO Data, CDC Data, Internal Market Research, Published Literature)
[ ] Estimated Patient Population (Millions)
[ ] Unmet Medical Need Assessment Summary
[ ] Supporting Data Files (Market Research, Epidemiology)
[ ] Target Validation Approach (Genetic Studies, Cellular Assays, Animal Models, Combination)
[ ] Date of Target Validation Milestone Completion

--- DRUG DISCOVERY ---
[ ] Initial Target Hypothesis
[ ] Target Validation Method (Genetic Studies, Cellular Assays, Animal Models, Literature Review)
[ ] Number of Initial Hit Compounds
[ ] Initial Screening Data Files
[ ] Screening Technologies Used (High-Throughput Screening (HTS), Fragment-Based Screening, Virtual Screening, Affinity Chromatography)
[ ] Date of Initial Hit Identification

--- PRECLINICAL DEVELOPMENT ---
[ ] Rationale for Preclinical Study Design
[ ] In Vitro Assay Raw Data
[ ] Maximum Tolerated Dose (MTD)
[ ] Start Date of In Vivo Toxicology Study
[ ] Animal Species Used in Toxicology Studies (Rat, Mouse, Dog, Other)
[ ] Toxicology Endpoints Evaluated (Clinical Chemistry, Hematology, Histopathology, Body Weight, Food Consumption)
[ ] Summary of Key Findings from Preclinical Studies

--- FORMULATION DEVELOPMENT ---
[ ] Target Dosage (mg)
[ ] Dosage Form (Tablet, Capsule, Oral Solution, Injection, Other)
[ ] Excipient Selection Rationale
[ ] Preliminary Formulation Data (e.g., solubility, stability)
[ ] Particle Size (Âµm)
[ ] Polymorphic Form (Form I, Form II, Other)
[ ] Formulation Optimization Completion Date

--- CLINICAL TRIAL PLANNING (PHASE 1) ---
[ ] Clinical Trial Protocol Summary
[ ] Protocol Approval Date
[ ] Planned Number of Participants
[ ] Primary Endpoint Measurement (Pharmacokinetics (PK), Pharmacodynamics (PD), Safety & Tolerability)
[ ] Key Inclusion Criteria (Age >= 18, Confirmed Diagnosis, Stable Medication Regimen, Adequate Organ Function)
[ ] First Patient Enrollment Planned Date
[ ] Investigator's Brochure (IB) Review & Updates

--- CLINICAL TRIAL EXECUTION (PHASE 1) ---
[ ] Patient Enrollment Start Date
[ ] First Patient Dosing Date
[ ] Number of Patients Enrolled
[ ] Adverse Event Reporting Summary (Phase 1)
[ ] Investigational Product Batch Number (Batch 1, Batch 2, Batch 3)
[ ] Dosing Time (Example Patient)
[ ] Patient Consent Form (Sample)

--- CLINICAL TRIAL PLANNING (PHASE 2) ---
[ ] Detailed Protocol Description
[ ] Planned Patient Enrollment Number
[ ] Planned Study Start Date
[ ] Estimated Study End Date
[ ] Primary Endpoint Measurement Method (Objective Measurement, Patient Reported Outcome, Clinical Assessment)
[ ] Investigational Site Selection Criteria (Patient Population Availability, Investigator Experience, Equipment Capabilities, Regulatory Compliance)
[ ] Statistical Analysis Plan Review Status (Not Started, In Progress, Completed)
[ ] Statistical Analysis Plan Document

--- CLINICAL TRIAL EXECUTION (PHASE 2) ---
[ ] Patient Enrollment Start Date
[ ] Patient Enrollment End Date
[ ] Number of Patients Enrolled
[ ] Summary of Adverse Events Reported
[ ] Data Monitoring Committee (DMC) Review Status (Pending, Completed, Deferred)
[ ] Data Quality Checks Completed? (Data Entry Verification, Source Data Verification, Query Resolution)
[ ] Time of Critical Event (e.g., Serious Adverse Event)
[ ] Clinical Study Report Draft

--- CLINICAL TRIAL PLANNING (PHASE 3) ---
[ ] Phase 3 Trial Protocol Summary
[ ] Planned Number of Participants
[ ] Primary Endpoint Measurement Method (Subjective Assessment, Objective Measurement, Biomarker Analysis)
[ ] Planned First Patient Enrollment Date
[ ] Estimated Trial Completion Date
[ ] Key Inclusion Criteria (Age Range, Disease Stage, Prior Treatment History, Specific Biomarker Status)
[ ] Statistical Analysis Plan (SAP)

--- CLINICAL TRIAL EXECUTION (PHASE 3) ---
[ ] Trial Start Date
[ ] Number of Participants Enrolled
[ ] Summary of Protocol Deviations (if any)
[ ] Data Monitoring Committee (DMC) Review Status (Pending, Completed - No Concerns, Completed - Concerns Identified, Completed - Recommendation Made)
[ ] Date of Last Safety Review
[ ] Key Findings from Interim Analysis (if applicable)
[ ] Interim Analysis Report (if applicable)
[ ] Investigational Product Accountability Status (Complete and Accurate, Minor Discrepancies, Significant Discrepancies)

--- REGULATORY SUBMISSION (NDA/MAA) ---
[ ] Summary of Clinical Data
[ ] Clinical Study Reports (CSRs)
[ ] Patient Enrollment Numbers
[ ] Submission Date
[ ] Regulatory Agency (FDA, EMA, Other)
[ ] Description of Manufacturing Process
[ ] CMC Data

--- MANUFACTURING PROCESS DEVELOPMENT & VALIDATION ---
[ ] Process Flow Description
[ ] Critical Process Parameter (CPP) - Temperature (Celsius)
[ ] CPP - pH
[ ] Equipment Validation Status (Not Started, In Progress, Completed, Failed)
[ ] Process Validation Protocol Document
[ ] Process Validation Start Date
[ ] Process Validation Completion Date
[ ] Critical Quality Attributes (CQA) Addressed (Purity, Potency, Dissolution, Moisture Content, Particle Size)

--- POST-APPROVAL ACTIVITIES & PHASE 4 TRIALS ---
[ ] Phase 4 Trial Start Date
[ ] Summary of Post-Approval Safety Data
[ ] Number of Adverse Events Reported
[ ] Protocol Deviations Identified? (Yes, No)
[ ] Supporting Documentation (e.g., Safety Reports)
[ ] Summary of Risk Management Plan Updates
[ ] Next Periodic Safety Update Report Due Date

--- INTELLECTUAL PROPERTY MANAGEMENT ---
[ ] Patent Application Number(s)
[ ] Filing Date (Patent Application 1)
[ ] Filing Date (Patent Application 2)
[ ] Trademark Registration Number(s)
[ ] Patent Status (Application 1) (Filed, Published, Pending, Granted, Abandoned, Expired)
[ ] Number of Patent Claims
[ ] Summary of IP Strategy
[ ] Copies of Patent Documents

--- PROJECT MANAGEMENT & REPORTING ---
[ ] Project Budget (Total)
[ ] Actual Spend to Date
[ ] Project Start Date
[ ] Projected Completion Date
[ ] Project Status (Not Started, In Progress, On Hold, Completed, Cancelled)
[ ] Key Risks & Mitigation Strategies
[ ] Project Dashboard Report
[ ] Reporting Frequency (Weekly, Bi-Weekly, Monthly)

--- END OF TEMPLATE ---
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