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CRD TEAM

Inhalation

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.

Veeda Infrastructure

  • State of art negative-pressure room for dosing activity for respiratory medications at vedant faciltiy of Veeda.
  • A uniform environment with relatively consisitent 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.

Veeda’s Experience for Inhalation Studies

  • We have so far conducted 18 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.

WHY PARTNER WITH VEEDA?

  • Proper understanding of inhalation studies and associate challenges, for clinical development phase.
  • Highly skilled & Excellent scientific expertise: focused on client’s special requirements & capable of handling challenging studies.
  • Skilled project management with Robust and Proactive communication.
  • Start of Art infrastructure for Inhalation studies e.g
    • Excellent compliance volunteers database for complex studies.
    • Full temperature and humidity control clinical facility.
    • Adequate facility for IMP storage.
  • Focused on volunteer training for smooth execution of Inhalation.
  • Past experience of conducting Inhalation study with large no. of Volunteer.
  • Well trained Physicians and Nurses, available round the clock during clinical execution phase, capable of handling any emergency.
  • Good understanding of regulatory requirements.
  • Management focus on training of staff for challenging and complex studies.

Our exemplary regulatory track record

USFDA
33 times
Brazil ANVISA
7 times
WHO
5 times
UK MHRA
3 times
EU - AGES
1 times
South Africa - MCC
1 times
NPRA - Malaysia
4 times
DCGI
13 times