Cardiac Safety
Case Report
Form design
Institutional Review Board submissions
Recruiting of healthy subjects and special populations
Phenotyping/genotyping studies
Phase I-III/bioequivalence clinical trials
Adverse event coding and reporting
Electronic data submission and electronic reports
Quality assurance
Experience
First time in
human
Pharmacokinetics
Pharmacodynamics
Bioavailability
Bioequivalence
Drug interaction
Genotyping studies
Food effects
Safety and tolerability
Age/gender
Single and multiple dose escalation with on-line PK analysis
Skin irritation and sensitization studies
Dermal PK
Drug delivery In vivo testing
Medical devices
Vasoconstrictor
Vaccines
Special Populations Database
Healthy male/female
Surgically sterile/postmenopausal women
Postmenopausal women
Healthy premenopausal women with regular menstrual cycles with and without
oral contraceptives
Osteo/rheumatoid arthritis
Asthmatic (adult/pediatric)
HIV positive
Hepatitis C
Allergic rhinitis
Healthy geriatric/pediatric
Diabetics, type I and II
Hypertensive
Cardiovascular diseased
Patients with peptic ulcer (PUD) and gastroesophageal reflux (GERD)disease
Obese subjects
Fast/slow metabolizers in CYP2D6, CYP2C9, and CYP2C19
Healthy pediatric subjects
Elderly subjects
Therapeutic Areas
Cardiovascular
system
Central nervous system
Dermatology
Endocrinology
Gastrointestinal
Genitourinary
Hyperlipidemia
Hypertension
Immunology
Infectious diseases
Ophthalmology
Pain management
Pulmonary
Women's health
