DRUGS

Concentrics works with drugs in a variety of therapeutic areas.  These include, but are not limited to the following:

Therapeutic Areas

Gastrointestinal

  • Heartburn
  • Constipation
  • IBS
  • GERD

Respiratory

  • Allergy
  • Asthma
  • Cough/Cold
  • Influenza

Urology

  • Incontinence
  • BPH
  • UTI
  • OAB

Dermatology

  • Alopecia
  • Eczema
  • Psoriasis
  • Acne
  • Sunscreen
  • Hives
  • Hair Removal

Chemical Dependence

  • Smoking Cessation
  • Tobacco Dependence
  • Drug Abuse

Endocrinology

  • Diabetes
  • Nutrition and Weight Loss
  • Low Testosterone

Ophthalmology

  • Contact lens solutions
  • Eye drops
 Central Nervous System/Pain Management

  • Pain
  • Headache
  • Backache
  • Migraine
  • Sleep
  • Joint and Muscle Pain

Women’s Health

  • Vaginitis
  • Sexual Dysfunction
  • Menopause
  • Tampon use
  • Birth Control
  • HRT
  • Bacterial vaginitis

Infectious Disease

  • Herpes
  • HIV

Cardiovascular

  • Cholesterol lowering
  • Home defibrillators
  • Blood pressure
  • Blood pressure monitors

Oral Healthcare

  • Whitening
  • Gingivitis
  • Tartar
  • Plaque
  • Cavity prevention
  • Denture cleansers/adhesives

Autoimmune

  • Osteoarthritis
  • Rheumatoid arthritis

 

CDER FDA Interactions

Concentrics has excellent working relationships with key leaders in the Center for Drug Evaluation Research (CDER) and the Office of Nonprescription Products which includes the Division of Nonprescription Clinical Evaluation (DNCE) for NDA products and the Division of Nonprescription Regulation Development (DNRD) for monograph products.

Concentrics also works with key leaders within the Office of Surveillance and Epidemiology (OSE) for Risk Evaluation and Mitigation Strategies (REMS) and work with medication guides and other health communications.  Another important area of interaction is with the Division of Medication Errors Prevention and Analysis (DMEPA) who work with proprietary names and umbrella branding issues.

 Types of Studies

  • Clinical Trials
    • Phase I trials (outpatient and exploratory, proof-of-concept)
    • Phase II trials (dose ranging, safety, efficacy)
    • Phase III trials (safety, efficacy)
    • Phase IV trials (long term safety, claims, phase IV commitments, REMS, special populations, quality of life, patient reported outcomes)
  • Rx-to-OTC Switch Studies
    • Label Comprehension
    • Self-selection/Self-diagnosis
    • Actual Use
  • Claims Studies
    • Marketing or clinical claims
    • Superiority
    • Parity
    • Non-inferiority