Clinical Trial Medications and Specialized Preparations
Boulevard Pharmaceutical Compounding center has experience in the preparation of medications for clinical trials and specialized preparations. We can facilitate the processing of quantities desired in blinded or open-label formats of the study medication. We can do this in various forms, including capsules, sterile injections, sterile preservative-free eye drops, nasal sprays, transdermal creams and gels, topical sprays, suppositories, and sublingual drops. If you need additional variables in drug delivery, we can work with you in addressing the challenges you face in these critical research study situations.
We can custom compound medication forms with active or placebo dosage forms
We can provide these medications in patient trial kits with patient information or other required documentation. For blinded trial medications, both the study medication and placebo will be appropriately labeled for study coordinator key reference.
CRITERIA FOR CLINICAL TRIALS
All formulas and samples must be designated “For Investigational Use Only”.
Master formula should include:
- Product name or number (NIH)
- Study identification name or number
- Dosage strength
- Dosage form
- Ingredient name and quantity
- Total theoretical weight if applies
- Approval date and signature
Compounding record (all that is in master formula record):
- Compounding instructions
- Lot numbers
- Expiration dates
- Order of addition
- Equipment used
- Temperature if important
- Mixing speeds and times
- Storage conditions
- Test results if needed
- Certificate of analysis on all ingredients
- MSDA if applicable
- Calibration test on equipment
Notes: Precautions, safety issues, measures taken in adverse events.
Packaging: Blister pack dosage cards of 30 or 60 capsules with weeks/months dosages pre-loaded may be added to the study.
Pricing: Based on individual study and dependent on Pharmacists hours and certified techs hours needed to complete study.
Still have questions or concerns? Contact our pharmacist today for more information.