Allergy/Respiratory Experience
Asthma
- Preparation of a full NDA, including ISS, ISE, Summary of Risk Benefit, Summary of Statistical Methodology and other summary sections for an oral asthma medication (Approved)
- A Phase IV randomized large and long-term, double blind, placebo-controlled, multi-center study for an oral asthma medication
- Three Phase I randomized, single-center, single-dose, cross-over, bioavailability studies for a drug indicated for asthma
- A Phase I dose escalation study in mild asthmatics
- Statistical analyses for Phase IV publication support program of an oral asthma medication
- European submission of a steroid metered-dose powder inhaler (MDPI) for the treatment of asthma, including a multi-center international Phase III study conducted in Eastern Europe
- Commercialization support of a marketed oral asthma medication, including a Phase IV trial in nocturnal asthmatics
COPD, and AECB
- Seven Phase I and Phase II studies from protocol design through finalization of the clinical study reports for a long-acting anticholinergic agent used in the treatment of COPD; this compound was under development in both MDI and nebulized formulations
- Phase IV support of an oral antibiotic indicated for AECB, including pharmacoeconomic analyses for formulary submission and a Phase IV trial
Allergic Rhinitis and Allergic Conjunctivitis
- An NDA for a nasal steroid used to treat allergic rhinitis, including CSRs for 13 clinical studies, ISS, ISE, the Statistical Methodology summary section
- Six studies (Phase I through Phase III) for a soft steroid administered intranasally for allergic rhinitis
- NDA for an ocular antihistamine to treat allergic conjunctivitis: preparation of the ISS, ISE, Application Summary, pre-clinical sections, and individual study reports of 19 studies
Read More:
Respiratory Experience of
PROMETRIKA, LLC PDF
