Paracetamol 500 mg CTD Dossier
Module 1 - Administrative & Regional Information (2 pages)
- Cover Page: Paracetamol 500 mg, Applicant: [Mock Pharma Inc.]
- Table of Contents
- Applicant and Manufacturer Details
- Proposed Labeling Summary
Module 2 - Quality, Nonclinical, Clinical Summaries (5 pages)
2.1 Quality Overall Summary
- Drug Name: Paracetamol 500 mg Tablet
- Dosage Form: Oral Tablet
- Strength: 500 mg
- Manufacturing Process Overview: API synthesis, granulation, compression, coating
2.2 Nonclinical Overview
- Pharmacology: Analgesic, Antipyretic activity in vitro and in vivo
- Toxicology Summary: Acute, sub-chronic studies in rodents; No genotoxicity observed
2.3 Clinical Overview
- Pharmacokinetics: Tmax 0.5-1 hr, Half-life 2-3 hr
- Efficacy: Effective for mild to moderate pain and fever
- Safety: Rare hepatotoxicity with overdose
Module 3 - Quality (10 pages)
3.1 Drug Substance (API)
- Description: White crystalline powder
- Structure: C8H9NO2
- Manufacturing Process Flowchart: API synthesis steps
- Specifications & Testing Methods: Identification, Assay, Purity, Residual solvents
3.2 Drug Product (Formulation)
- Composition Table: API, Excipients, Tablet weight
- Manufacturing Process: Blending, granulation, compression, coating
- Flow Diagram: Stepwise process visualization
- Specifications: Hardness, Dissolution, Content uniformity, Microbial limits
- Stability Data (Mock): 24 months at 25°C/60% RH, 6 months at 40°C/75% RH
3.3 Packaging & Labeling
- Mock Package Insert
- Storage Conditions: Store below 25°C, protect from moisture
- Blister and Bottle Packaging Description
Module 4 - Nonclinical Study Reports (3 pages)
- Pharmacology Studies: Analgesic efficacy in rats, antipyretic in rabbits
- Toxicology Studies: Single dose (LD50 > 2000 mg/kg), Repeat dose 28-day study, No significant
toxicological effects
- Safety Summary Tables: Hepatic, Renal, Hematology, Histopathology results (mock data)
Module 5 - Clinical Study Reports (5 pages)
- Clinical Pharmacology Summary: Absorption, Distribution, Metabolism, Excretion
- Bioequivalence Study Reports (Mock): Tablet vs Reference, Cmax, AUC, Tmax values
- Safety and Efficacy Tables: Adverse Events, Lab Abnormalities, Efficacy Endpoints
- Proposed FDA Labeling (Full Format):
- Indications & Usage
- Dosage & Administration
- Contraindications
- Warnings & Precautions
- Adverse Reactions
- Drug Interactions
- Use in Specific Populations
- Overdosage
- Description, Storage & Handling, Packaging
Appendices (1 page)
- References (Mock: PubMed, FDA Guidelines, ICH Guidelines)
- Glossary & Abbreviations
End of Dossier
