DRUG STUDIES AND RESEARCH
Many investigational drug or nutrient studies require the distinctive abilities and flexibility of a compounding pharmacy. O’Brien Pharmacy is a PCAB-accredited pharmacy and an experienced, cost-effective supplier of matching active and placebo dosage forms for clinical studies. In addition, O’Brien Pharmacy provides consultation, compounding and dispensing services for FDA-approved clinical drug trials, including storage, randomization, dosing and documentation required for study validation. We have identified and resolved procedural, material, equipment and calculation issues for clients, increasing accuracy and efficiency. Please see “Experience” listed below.
We know the importance of fulfilling these orders on a timely basis, with proper packaging, labeling and independent laboratory verification of both active and placebo. And we have worked with clinicians studying drugs or nutrients in both humans and animals from a few hundred to tens of thousands of doses.
O’Brien Pharmacy is uniquely qualified and experienced to satisfy the individualized requirements of many study investigations including:
- Special dosage forms including sterile
- Matching active and placebo
- Special flavorings
- Proper excipient selection
- Appropriate laboratory documentation
- Storage, handling and expiration issues
- Budget considerations
Call or email O’Brien Pharmacy for your special study needs.
Please review some of our experience below.
Experience: Drug Study Provider / Associate
- Member of the Hunkeler Eye Centers Institutional Review Board, overseeing 95 FDA studies on ophthalmic research, including refractive surgical procedures and new drug therapies. 1993-1996
- University of Kansas Medical Center
Bio-Identical Hormone Replacement (troche), Placebo (troche)
1998 - Novartis Pharmaceutical Corporation
East Hanover, NJ
Proprietary
2000 - Transdermal Therapies for Neuropathy
University of Missouri – Kansas City School of Pharmacy and Drug Information Center
The Neuropathy Association, Greater Kansas City Support Group
Neurological Consultants of Kansas City
Actives, Placebo
2001 - Ohio State University
Department of Veterinary Clinical Sciences
Glucosamine 750mg, Glucosamine 350mg, Placebo
2003 - St. Luke’s Hospital Lipid and Diabetes Research
Kansas City, MO
Nicotinic Acid, Placebo
2003 - Metro Health Medical Center
Division of Gastroenterology
Cleveland, Ohio
Zelnorm, Placebo
2004 - UMKC School of Dentistry / Children’s Mercy Hospital
Ibuprofen, Acetaminophen, Placebo
2007 - Shire Pharmaceuticals
Wayne, PA 19087
Proprietary
2007 - Acambis Pharmaceuticals
Cambridge, MA 02139
Flu Vaccine
2007, 2008 - Inotek Pharmaceuticals
Beverly, MA 01915
Ophthalmology
2008 - Consulting Pharmacy, Johnson County Clin-Trials
Lenexa, KS
2005 to present - University of Kansas Medical Center
Kansas City, KS 66160
Aspirin / Niacin / Pectin / Placebo
2009 - HHT Foundation International
Monkton, MD 21111
FDA application for topical nasal therapies for HHT
2009-2016 - Cleveland BioLabs
Cleveland, OH
Sterile Buffered Drug Diluent
2008-2015 - GlaxoSmithKline
Proprietary
2011-2012 - University of Kansas Medical Center
SPARQ Statin Study
2011-2012 - Children’s Mercy Hospital
Kansas City, MO
Ketotifen
2015-2016 - Children’s Mercy Hospital
Kansas City, MO
IV Glucose Isotope
2015-2016 - University of Kansas Medical Center
Kansas City, MO
Budesonide
2016