Pulmonary diseases can be quite variable in both presentation and etiology. Some diseases like cystic fibrosis are caused by genetic defects, while others may arise from environmental exposure to things like asbestos or cigarette smoke or exposure to infection with a pathogen such as influenza or mycobacterium tuberculosis.
Certain conditions like pulmonary hypertension may affect not only the lungs but also other body systems, such as the cardiovascular system, which can add further complexity to treatment.
In addition to the wide variety of pulmonary diseases, the lungs themselves can be an attractive route of administration due to their large surface area and high degree of blood vessel perfusion. However, due to the inherent safety concerns related to inhaled drugs, pulmonary drug development requires careful planning and management.
Pulmonary studies, especially those with a pharmacokinetic component, may require additional consideration regarding study design, data analysis, and interpretation of results in light of differences in pulmonary absorption versus other routes of administration. Nuventras’s consultants have extensive experience developing drugs to treat respiratory disorders, as well as inhaled drugs intended to treat non-pulmonary diseases, across all stages of development.
Nuventra’s Pulmonary Experience
Nuventra can perform any of our wide range of services for drugs to treat Pulmonary indications. Some of our recent project experience in this area includes:
- Clinical Operations
- Early Phase Clinical Trial Management
- Clinical Pharmacology Strategy
- IND Submission
- Regulatory Strategy
This experience includes a variety of dosage forms, including:
- Drug-Device Combination Product Development
- Inhaled Dry Powder Formulations
Visit our services page to see our full range of services and to learn more about what our drug development consultants can offer your program.
Nuventra has worked on a number of pulmonary indications, including:
- Chronic obstructive pulmonary disease
- Idiopathic Pulmonary Fibrosis
- Interstitial Lung Disease
- Pulmonary Arterial Hypertension
- Pulmonary Hypertension
- WHO Groups 1-4