Inhalation Toxicology

Planning the right studies for your development programme

A well-planned nonclinical development programme starts with understanding the drug, the available scientific evidence and the requirements of the next stage of development.

Regulatory guidance provides an important framework, but each programme needs to be considered in the context of the particular compound, its intended use and the data already available.

AlbaTox helps clients identify and plan appropriate nonclinical studies, considering scientific objectives, regulatory expectations, practical requirements and development timelines.

Support can begin before a study programme has been agreed, helping sponsors evaluate their options and make informed decisions before committing to research activities.

Areas of support

• Nonclinical development planning and study strategy.
• Identification of appropriate studies and their timing.
• Study design and protocol development or review.
• Assessment of relevant regulatory requirements.
• Identification and evaluation of suitable CROs.
• Review of study proposals, budgets and timelines.
• Specialist advice on inhalation toxicology study requirements.

With extensive practical experience in inhalation toxicology, AlbaTox can also support programmes involving inhaled pharmaceutical products, including the development of new inhaled therapies and alternative inhalation routes for existing medicines.

The aim is to develop an appropriate, scientifically justified programme that addresses the questions relevant to each stage of development.

Independent scientific oversight throughout your studies

Once a nonclinical study has been commissioned, effective oversight helps ensure that the work remains aligned with the sponsor's scientific objectives.

For companies without dedicated in-house toxicology expertise, working with a CRO can involve complex technical decisions, detailed study documentation and unexpected challenges.

AlbaTox provides independent CRO oversight and study monitoring, acting as an experienced scientific representative for the sponsor.

Drawing on many years of experience working within contract research organisations, Viktoria understands the practical realities of conducting toxicology studies, from initial planning through to the interpretation and reporting of results.

Areas of support

• Acting as the sponsor's scientific representative.
• Reviewing study protocols and associated documentation.
• Liaising with CRO study directors and scientific teams.
• Conducting on-site study monitoring visits.
• Reviewing study progress and identifying potential issues.
• Supporting the assessment and resolution of scientific or operational challenges.
• Reviewing draft study reports and discussing findings with the CRO.
• Communicating relevant developments and findings to the sponsor.

Experience on both sides of the relationship

Having worked within CROs before moving into consultancy, Viktoria brings an understanding of both the research facility's responsibilities and the sponsor's requirements.

This experience helps her work constructively with study teams, ask relevant questions and provide informed scientific input throughout the study.

Her involvement can extend from the initial planning stages through to review of the final study report, or focus on a particular stage where additional expertise is required.

Bringing the wider development programme together

Nonclinical drug development involves more than individual toxicology studies.

Information from pharmacology, in vitro research, in vivo studies and other scientific disciplines needs to be considered together to support development decisions.

For companies requiring broader support, AlbaTox can provide scientific leadership and coordination of nonclinical development activities.

This may be particularly valuable for smaller biotechnology companies that have specialist scientific teams but do not have an experienced nonclinical development lead within the organisation.

Areas of support

• Development and coordination of nonclinical programmes.
• Planning activities around development objectives and milestones.
• Working with CROs and external scientific specialists.
• Reviewing and integrating findings from different studies.
• Identifying scientific questions and development risks.
• Providing nonclinical input to multidisciplinary development teams.
• Supporting decisions relating to progression towards clinical development.

Understanding the transition to clinical development

Viktoria's background includes practical experience in first-in-human clinical trials, where nonclinical findings are used to inform clinical study planning and safety considerations.

This provides an additional perspective when evaluating nonclinical data and considering its relevance to the next stage of development.

AlbaTox can support clients with the wider scientific picture while recognising when additional specialist expertise is required.

Specialist advice when scientific questions arise

Not every project requires a complete nonclinical development programme or ongoing study oversight.

Sometimes a company needs an independent scientific opinion, help interpreting unexpected findings or support with a particular regulatory question.

AlbaTox provides focused scientific and regulatory support, drawing on practical toxicology experience and an understanding of how nonclinical data contributes to drug development decisions.

This can involve reviewing an individual study, considering findings alongside other available evidence or helping a development team evaluate its options.

Areas of support

• Scientific review and interpretation of nonclinical data.
• Assessment of unexpected toxicology findings.
• Integration of information from different studies and scientific disciplines.
• Review of nonclinical study reports and supporting documentation.
• Preparation or review of relevant nonclinical regulatory documents.
• Scientific input to regulatory questions and interactions.
• Independent advice on specific nonclinical development challenges.

Looking at the complete scientific picture

An individual toxicology finding cannot always be considered in isolation.

Its significance may depend on the compound, its pharmacology, the intended patient population, the route of administration and other available evidence.

AlbaTox takes these wider considerations into account when providing scientific advice, helping clients evaluate findings in the context of their development programme.