Inhalation products belong to topical drug delivery systems. They are delivered through pulmonary route. These studies require experienced staff, necessary infrastructure and extensive training to volunteers for standardize the dosing procedure. We understand your need. Choose Veeda for its skilled team that has the right scientific expertise to cater to client-specific requirements. Veeda’s state of art infrastructure and stable record of accomplishment with respect to regulatory compliance, quality, and ethics makes it a go-to CRO for perfect handling and execution of inhalation studies.
- State of art negative-pressure room
- For enhanced regulatory dosing compliance.
- For a stable environment that maintains constant temperature, humidity, air flow, and oxygen concentration.
- Eliminates chances of cross-contamination.
- A uniform environment with relatively consistent temperature, humidity, airflow, oxygen content and other major environmental factors for all respiratory dosing.
- Better Respiratory dosing compliance.
- Specifications of Negative- Pressure room.
- Change Room 1 (at 25PA, 3 people can be accommodated at a time)
- Dosing Room 1 & 2(at 10PA, 3 people can be accommodated at a time)
- Change Room 2 (at 25PA, 3 people can be accommodated at a time)
- Advantages of Negative-pressure room.
- Provides a uniform environment with relatively consistent temperature, humidity, airflow, oxygen content and other major environmental factors for all respiratory dosing.
- Eliminates any chance of cross contamination from one dosed subject to another during dosing procedure.
- Better regulatory acceptance due to assured well-controlled dosing procedure.
- 46 LC/MS/MS- (from lower to high sensitive equipment’s)
- Sciex- API2000/3200/3000/4000/5500
- Shimadzu- 8040/8050/8060
Veeda’s Experience for Inhalation Studies
- We have so far conducted 22 studies (13 pMDI+4 DPI+1 Nasal spray) for inhalation products and few more are in pipeline.
- Total no. of volunteers dosed till date: 800+
- Total no. of studies on DPI (dry Powder inhalation) – 04.
- Total no. of volunteers dosed: 96.
- Total no. of studies on pMDI (Pressurized metered dose inhalation) – 13.
- Total no. of volunteers dosed: 692.
Training of Volunteers
Veeda provides training to the volunteers for these studies. Monitoring is done to see the inhalation flow with respect to time and translate this into turbulent energy, acceleration rates and inhalation volumes. It is important to train volunteer before study participation for.
- To have required uniform inhalation rate.
- Training of co-ordination between actuation of pMDI and inhalation.
- Proper inhalation technique without any leakage during inhalation.
- Training of volunteers using Practice placebo inhaler, Aerosol Inhalation Monitor (AIM), In-check DIAL meter. 2-tone device.
- To educate on the proper inhalation technique devoid any leakage
- To understand uniform inhalation rate
- For precise interpretation of inhalation flow with respect to time
Veeda’s commitment to patient safety
- Well-equipped & well-maintained ICU
- Professional GCP trained staff, BLS trained paramedics, as well as ACLS & BLS trained physicians
- In-house ambulance
- Fire & chemical hazard systems
- Patient comfort and ease of mobility assured by using stature lifts and resuscitation.