Clinical Endpoint Bioequivalence

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Clinical Endpoint Experience

Our team has extensive expertise in designing and conducting clinical endpoint bioequivalence trials for a variety of topical and locally-acting generic products, having worked together on over 140 clinical endpoint protocols. Our protocols have addressed the following indications, among others:

 

Acne Rosacea                                        Dry Eye Syndrome                                       Osteoarthritis

Acne Vulgaris                                       Herpes Labialis                                            Pediculosis Capitis

Actinic Keratosis                                 Hypogonadism                                             Plaque Psoriasis

Asthma                                                   Icthyosis Vulgaris                                        Scabies Infestation

Atopic Dermatitis                                Impetigo                                                          Schizophrenia (BE)

Atrophic Vaginitis                              Molluscum Contagiosum                            Seborrheic Dermatitis

Bacterial Conjunctivitis                     Neuroblastoma (BE)                                     Tinea Capitis

Bacterial Vaginosis                            Non-Small Cell Lung Cancer                      Tinea Pedis

Blepharokeratoconjunctivitis          Onychomycosis                                               Tinea Versicolor

Common Wart                                      Open Angle Glaucoma                                  Vaccines (drug/device)

Condyloma Acuminata                      Oral Candidiasis                                             Vulvovaginal Candidiasis

 

Our experience in the area of generic drug development allows our clients to take advantage of the most up-to-date information available from the FDA and other regulatory agencies, reducing protocol and application review time and ultimately speeding the approval process. We are currently working with the Office of Generic Drugs on a protocol review initiative which promises dramatic reductions in review times.

Dr. Harris has participated in the design and review of many clinical trial studies during his work with Appian International Research, Inc. and SFBC International. He has contributed to the design of many clinical trial protocols, with a strong focus on dermatology and ophthalmology clinical endpoint bioequivalence.

 

 
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