Phase I Capabilities
Phase I Experience: Healthy Volunteers
Phase I Experience: Special Population
Therapeutic Areas
Phase I Capabilities
Clinical Pharmacology
- First-in-Human (First in Man)
- SAD and MAD PK Studies
- Healthy vs. Patient population
- Drug Interactions
- Cardiac Safety (e.g. TQTc study)
Special Population
- Renal Impairment
- Hepatic Impairment
- Diabetes
- Age, gender, etc.
PK/PD
- Dose selection
- Efficacy vs. Safety
Biopharmaceutics
- Bioavailability/Bioequivalence (BA/BE)
- Food Effect
Phase I Experience: Healthy Volunteers
- Bioavailability/Bioequivalence (BA/BE)
- Ascending Dose
- QT/QTc Safety
- PK/PD
- Food Effect (Fed/Fasted)
- Vaccines
- Drug-to-Drug Interaction
- Maximum Tolerated Dose
- Drug Transfer
- Single/Multiple Dose
- Patch Testing
- Devices
Phase I Experience: Special Population
- Hepatic impairment
- Hepatic impairment, including, but not limited to, Hepatitis A, B, and C
- Hepatic classifications as Child-Pugh A, Child-Pugh B, and Child-Pugh C (mild, moderate, and severe)
- Renal Insufficiency
- Classification as Mild, Moderate, and Severe, including Dialysis
- Type I Diabetes
- Type II Diabetes
- Elderly
- Hypertension
- Pre/Postmenopausal
- Obesity
- Immunology
- Plaque Psoriasis
- Rheumatoid arthritis
- Lupus
Therapeutic Areas
- Cardiology/Vascular Diseases
- Dermatology
- Endocrinology
- Gastroenterology
- Hematology
- Hepatology (Liver, Pancreatic, Gall Bladder)
- Immunology
- Infectious Diseases
- Musculoskeletal
- Nephrology
- Neurology
- Nutrition and Weight Loss
- Obstetrics/Gynecology (Women’s Health)
- Oncology
- Ophthalmology
- Orthopedics
- Otolaryngology (Ear, Nose, Throat)
- Pediatrics
- Podiatry
- Psychiatry/Psychology
- Pulmonary/Respiratory Diseases
- Rheumatology
- Urology
- Vaccines
Phase I services, Healthy Volunteers, Special Population
Phase I services, Healthy Volunteers, Special Population
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Headquarters:
2950 NW 83rd Street, Miami, Florida 33147
Hours of Operation:
Monday - Friday 8:00AM - 5:00PM
Main Contact: 305-220-2727