Table of Contents
eCTDer 0.3. Mon Mar 04 15:17:50 2002
Default operation: new
- 1 Administrative Information and Prescribing Information
- 2 Common Technical Document Summaries
- 3 Quality
- 3.2 Body of Data
- 3.2.S Drug Substance
- 3.2.S Drug Substance - Drug Substance Name - Manufacturer
- 3.2.P Drug Product
- 3.2.P Drug Product - Name
- 3.2.A Appendices
- 3.2.A.1 Facilities and Equipment
- 3.2.A.2 Adventitious Agents Safety Evaluation
- 3.2.A.3 Novel Excipients - Name
- 3.2.R Regional Information
- 3.3 Literature References
- 4 Nonclinical Study Reports
- 4.2 Study Reports
- 4.2.1 Pharmacology
- 4.2.2 Pharmacokinetics
- 4.2.2.1 Analytical Methods and Validation Reports (if separate reports are available)
- 4.2.2.2 Absorption
- 4.2.2.3 Distribution
- 4.2.2.4 Metabolism
- 4.2.2.5 Excretion
- 4.2.2.6 Pharmacokinetic Drug Interactions (nonclinical)
- 4.2.2.7 Other Pharmacokinetic Studies
- 4.2.3 Toxicology
- 4.2.3.1 Single-Dose Toxicity (in order by species, by route)
- 4.2.3.2 Repeat-Dose Toxicity (in order by species, by route, by duration, including supportive toxicokinetics evaluations)
- 4.2.3.3 Genotoxicity
- 4.2.3.4 Carcinogenicity (including supportive toxicokinetics evaluations)
- 4.2.3.4.1 Long-term studies (in order by species, including range-finding studies that cannot be appropriately included under repeat-dose toxicity or pharmacokinetics)
- 4.2.3.4.2 Short- or medium-term studies (including range-finding studies that cannot be appropriately included under repeat-dose toxicity or pharmacokinetics)
- 4.2.3.4.3 Other studies
- 4.2.3.5 Reproductive and Developmental Toxicity (including range-finding studies and supportive toxicokinetics evaluations) (If modified study designs are used, the following subheadings should be modified accordingly.)
- 4.2.3.5.1 Fertility and early embryonic development
- 4.2.3.5.2 Embryo-fetal development
- 4.2.3.5.3 Prenatal and postnatal development, including maternal function
- 4.2.3.5.4 Studies in which the offspring (juvenile animals) are dosed and/or further evaluated
- 4.2.4 Local Tolerance
- 4.2.5 Other Toxicity Studies (if available)
- 4.3 Literature References
- 5 Clinical Study Reports
- 5.2 Tabular Listing of all Clinical Studies
- 5.3 Clinical Study Reports
- 5.3.1 Reports of Biopharmaceutic Studies
- 5.3.1.1 Bioavailability (BA) Study Reports
- 5.3.1.2 Comparative BA and Bioequivalence (BE) Study Reports
- 5.3.1.3 In vitro - In vivo Correlation Study Reports
- 5.3.1.4 Reports of Bioanalytical and Analytical Methods for Human Studies
- 5.3.2 Reports of Studies Pertinent to Pharamacokinetics using Human Biomaterials
- 5.3.2.1 Plasma Protein Binding Study Reports
- 5.3.2.2 Reports of Hepatic Metabolism and Drug Interaction Studies
- 5.3.2.3 Reports of Studies Using Other Human Biomaterials
- 5.3.3 Reports of Human Pharmacokinetic (PK) Studies
- 5.3.3.1 Healthy Subject PK and Initial Tolerability Study Reports
- 5.3.3.2 Patient PK and Initial Tolerability Study Reports
- 5.3.3.3 Intrinsic Factor PK Study Reports
- 5.3.3.4 Extrinsic Factor PK Study Reports
- 5.3.3.5 Population PK Study Reports
- 5.3.4 Reports of Human Pharmacodynamic (PD) Studies
- 5.3.4.1 Healthy Subject PD and PK/PD Study Reports
- 5.3.4.2 Patient PD and PK/PD Study Reports
- 5.3.5 Reports of Efficacy and Safety Studies
- 5.3.5 Reports of Efficacy and Safety Studies - Indication Name
- 5.3.5.1 Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication
- 5.3.5.2 Study Reports of Uncontrolled Clinical Studies
- 5.3.5.3 Reports of Analyses of Data from More than One Study
- 5.3.5.4 Other Study Reports
- 5.3.6 Reports of Postmarketing Experience
- 5.3.7 Case Report Forms and Individual Patient Listings
- 5.4 Literature References