Table of Contents
Industry Experience: Design & Conduct of a Pregnancy PK Study
Treatment of B.V. and Flagylâ ER
Treatment of B.V. and Flagylâ ER
Metronidazole Pharmacokinetics
Metronidazole Pharmacokinetics
MTZ PK studies in Pregnancy
MTZ PK studies in Pregnancy
Flagylâ ER PK: Inclusion Criteria
Flagylâ ER PK: Inclusion Criteria
Flagylâ ER PK: Inclusion Criteria
Flagylâ ER PK: Procedures/Observations
Flagylâ ER PK: Procedures/Observations
Flagylâ ER PK: Procedures/Observations
Flagylâ ER PK: Procedures/Observations
Flagylâ ER PK: Procedures/Observations
Flagylâ ER PK: Sites - Patient Enrollment
Patient Enrollment
Patient Characteristics
Patient Characteristics
Total Metronidazole Plasma Levels
Metronidazole PK Statistics
Metronidazole PK Statistics
2-Hydroxy Metronidazole Levels
2-Hydroxy Metronidazole PK Stats
Ratio of Mean AUCs: 2-OH Metronidazole / Metronidazole
Metronidazole PK Statistics
Creatinine Clearance
Total Metronidazole Clearance
Metronidazole Renal Clearance
2OH-Metronidazole Renal Clearance
Metronidazole Nonrenal Clearance
Conclusions: Flagylâ ER 750 mg PK
Conclusions: Flagylâ ER 750 mg PK
Resolution of Bacterial Vaginosis
Resolution of Bacterial Vaginosis
Drug Administration in Pregnancy: Therapeutic Goals
Drug Administration in Pregnancy: Routes of Administration
Guidelines for Protocol Design
Pregnant Women are not Healthy Volunteers
Guidelines for Protocol Design
Pregnant Women are not a Homogeneous Population
When should we conduct trials?
When should we conduct trials?
Trials: Healthy Pregnant Women Exclusion Criteria
Trials in Pregnant Sub-Populations
Nonpregnant Comparator Options
Nonpregnant Comparator Options
Practical Aspects of Conducting Clinical Trials in Pregnant Women
Practical Aspects of Conducting Clinical Trials in Pregnant Women
Practical Aspects of Conducting Clinical Trials in Pregnant Women
Practical Aspects of Conducting Clinical Trials in Pregnant Women
Practical Aspects of Conducting Clinical Trials in Pregnant Women
Practical Aspects of Conducting Clinical Trials in Pregnant Women
Practical Aspects of Conducting Clinical Trials in Pregnant Women
Practical Aspects of Conducting Clinical Trials in Pregnant Women
Practical Aspects of Conducting Clinical Trials in Pregnant Women
Conclusions |
Author: Catherine Stika, MD Assistant Professor, Obstetrics & Gynecology Northwestern University Medical School
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