Specialized Clinical Trials
INAMED is a specialty CRO with particular expertise in inhalation medicine. In our own facility, we investigate your new medical device or your new drug by in-vitro and in such specialized clinical trials as:
- Lung Deposition of Radioactive Labeled Drugs / Lung Scintigraphy Trials
- Mucociliary and Alveolar Clearance
- Determination of Inhalation Patterns
- Acting as a Site in a Multicentre Trials
- Feasibility / Performance / Safety / Efficacy / BE / PK / PD Trials
- ADME 14C Investigations
- Sleep Laboratory Investigations
Lung Deposition
A key parameter for an effective inhalation device
Only a small amount of inhaled aerosol reaches those regions of the respiratory tract where it is needed. We characterize the effects of your formulation, of your device, and of your patient’s breathing patterns on drug deposition in the respiratory tract. Deposition data will help to optimize your device in the early phase of development. Likewise, to determine the dose of your drug that does reach the lungs, deposition trials
are the way to go.
INAMED uses sophisticated techniques to label your drug radioactively, and to visualize its deposition in the respiratory tract.
- Total and regional deposition using radiolabeled test aerosols or radiolabeled drugs
- Influence of breathing pattern on total and regional deposition with
Further Information:
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Determination of Inhalation Patterns
Please contact us for detailed information.
Download:
· Inhalation Flow Profile Studies.pdf
Mucociliary and alveolar clearance
Do you know the impact of your drug on lung clearance?
Your drugs could have positive or negative effects on lung clearance. We help you to characterize the effects of your drug on the lung clearance function.
- Short term clearance from conducting airways with radiolabelled test aerosols
- Long term clearance from the lung periphery using magnetic particles
- Imaging of intrapulmonary drug distribution using our 2D-graphic gamma camera or 3D gamma camera (SPECT) imaging
Pilot / Feasibility / Safety / Efficacy / BE / PK / PD trials
These trials are important early-phase tools for choosing the right path in drug development. INAMED assists in the important process of finding the right design for the trial. It is one of our specialties to help you to characterize your drug and its influence on the human respiratory tract by means of various lung function tests, deposition measurements, mucociliary clearance measurements and pharmacokinetic investigations.
Sleep Laboratory Investigations
State-of-the-art for your needs
Our experienced team and well-equipped facility make it possible for us to provide our customers with dependable sleep laboratory investigations
- 8 Beds
- State-of-the-art Equipment
- Monitored polysomnography
(staff, infra red video control, etc.) - Complete polysomnography recording
- AASM scoring, 2007 is possible
- > 12 years DGSM (German Society for Sleep Research and Sleep Medicine) accredited
- One of the TOP TEN in a recent quality study performed at 117 sleep laboratories
Lung Function Tests
Our laboratories are state-of-the-art
Should your drug/treatment have positive effects or no effect on your patient’s lung function parameters, our highly-trained staff can investigate lung function parameters in clinical studies for you.
- Bodyplethysmography
- Spirometry
- Ergospirometry
- Bronchial challenge
Should you need more detailed lung function data characterized, we provide:
- IOS - Impuls-Oscillometry to characterize central and peripheral lung resistance and reactance
- RAP - Respiratory aerosol probe to characterize peripheral airspace dimensions e. g. for the diagnosis of lung emphysema
- RMS - Respiratory mass spectrometry to characterize dead space volume and lung ventilation parameters.

