| Clinical Study |
5.3.1.1 – Biopharmaceutical > Bioavailability (BA) |
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5.3.1.2 – Biopharmacetical > Comparative Bioavailability (BA) and Bioequivalence (BE) |
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5.3.1.3 – Biopharmacetical > In Vitro - In Vivo Correlation |
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5.3.1.4 – Biopharmacetical > Bioanalytical and Analytical Methods |
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5.3.2.1 – Pharmacokinetics using human biomaterials > Plasma Protein Binding |
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5.3.2.2 – Pharmacokinetics using human biomaterials > Hepatic Metabolism and Drug Interactions |
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5.3.2.3 – Pharmacokinetics using human biomaterials > Other Human Biomaterials |
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5.3.3.1 – Human Pharmacokinetics (PK) > Healthy Subject Pharmacokinetic (PK) and Initial Tolerability |
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5.3.3.2 – Human Pharmacokinetics (PK) > Patient Pharmacokinetic (PK) and Initial Tolerability |
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5.3.3.3 – Human Pharmacokinetics (PK) > Intrinsic Factor Pharmacokinetic (PK) |
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5.3.3.4 – Human Pharmacokinetics (PK) > Extrinsic Factor |
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5.3.3.5 – Human Pharmacokinetics (PK) > Population Pharmacokinetic (PK) |
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5.3.4.1 – Pharmacodynamics (PD) > Healthy Subject Pharmacodynamics (PD) and PK/PD 5.3.4.2 – Pharmacodynamics (PD) > Patient Pharmacodynamics (PD) and PK/PD |
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5.3.5.1 – [Indication] > Efficacy and Safety > Controlled Clinical Studies |
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5.3.5.2 – [Indication] > Efficacy and Safety > Uncontrolled Clinical Studies |
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5.3.5.3 – [Indication] > Efficacy and Safety > Analyses of Data |
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5.3.5.4 – [Indication] > Efficacy and Safety > Other Studies |
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5.3.6 – Postmarketing Experience |
| Nonclinical Study |
4.2.1.1 – Pharmacology > Primary Pharmacodynamics |
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4.2.1.2 – Pharmacology > Secondary Pharmacodynamics |
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4.2.1.3 – Pharmacology > Safety Pharmacology |
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4.2.1.4 – Pharmacology > Pharmacodynamic Drug Interactions |
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4.2.2.1 – Pharmacokinetics > Analytical Methods and Validation Reports |
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4.2.2.2 – Pharmacokinetics > Absorption |
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4.2.2.3 – Pharmacokinetics > Distribution |
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4.2.2.4 – Pharmacokinetics > Metabolism |
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4.2.2.5 – Pharmacokinetics > Excretion |
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4.2.2.6 – Pharmacokinetics > Pharmacokinetic Drug Interactions |
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4.2.2.7 – Pharmacokinetics > Other Pharmacokinetic |
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4.2.3.1 – Toxicology > Single Dose Toxicity |
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4.2.3.2 – Toxicology > Repeat Dose Toxicity |
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4.2.3.3.1 – Toxicology > In vitro Genotoxicity |
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4.2.3.3.2 – Toxicology > In vivo Genotoxicity |
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4.2.3.4.1 – Toxicology > Long Term Carcinogenicity |
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4.2.3.4.2 – Toxicology > Short or Medium Term Carcinogenicity |
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4.2.3.4.3 – Toxicology > Other Carcinogenicity 4.2.3.5.1 – Toxicology > Fertility and Early Embryonic Development |
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4.2.3.5.2 – Toxicology > Embryofetal Development |
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4.2.3.5.3 – Toxicology > Prenatal and Postnatal Development |
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4.2.3.5.4 – Toxicology > Studies in Which the Offspring are Dosed or Evaluated |
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4.2.3.6 – Toxicology > Local Tolerance |
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4.2.3.7.1 – Toxicology > Antigenicity |
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4.2.3.7.2 – Toxicology > Immunotoxicity |
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4.2.3.7.3 – Toxicology > Mechanistic |
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4.2.3.7.4 – Toxicology > Dependence |
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4.2.3.7.5 – Toxicology > Metabolites |
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4.2.3.7.6 – Toxicology > Impurities |
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4.2.3.7.7 – Toxicology > Other Toxicity |
| Products |
2.3.P – Drug Product |
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3.2.P – Drug Product |
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3.2.A.1 – Facilities and Equipment |
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3.2.A.2 - Adventitious Agents Safety Evaluation |
| Active Substances |
2.3.S – Drug Substance |
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3.2.S – Drug Substance |
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3.2.A.1 – Facilities and Equipment |
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3.2.A.2 - Adventitious Agents Safety Evaluation |
| Inactive Ingredients |
3.2.P.4 Control of Excipients |
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3.2.A.3 Novel Excipients |
| Indications |
2.7.3 Summary of Clinical Efficacy |
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5.3.5 Reports of Efficacy and Safety Studies |