4. STUDY DESIGN

A. Longitudinal Design

B. Population PK Design

5. OTHER DESIGN CONSIDERATIONS

A. Study Participants

B. Postpartum Assessments

C. Sample Size

D. Drug
Administration

F. Studies with No Intended Therapeutic Benefit

G. Pharmacodynamic Assessments

6.DATA ANALYSIS

A. Parameter Estimation

B. Development of Dosing Recommendations

7. LABELING

A. Clinical Pharmacology

1. Pharmacokinetics Subsection

2. Special Populations Subsection

B. Precautions/Pregnancy

C. Dosage and Administration