Preclinical programs critical to supporting an investigational new drug (IND) application require significant time and resources. Protheragen has the experience and bioanalytical capacity to deliver accurate and regulatory-compliant pharmacokinetics, pharmacodynamics, biomarker, and immunogenicity data through our IND program services for mitochondrial disease.
What is IND Program?
IND-enabling studies aim to secure permission to execute first-time human trials with a new drug. The IND application comprises detailed pharmacology and toxicology data, information regarding the manufacture (such as the composition, production, and stability), human trial protocols, and details about the investigators.
Why is an IND application required?
The purpose of an IND application is to determine whether a new drug’s proposed effectiveness and safety profile, planned manufacturing process, and study human trial designs are acceptable for performing studies in human subjects.
Our Services
We have industry-leading expertise in all aspects of mitochondrial disease research, which enables us to aid our clients in launching and completing their IND-enabling programs within the planned budgets and defined timelines. In addition, we work with the clients to develop study programs for each particular drug, considering the type of drug, intended route of administration, and indication. The range of IND-enabling activities we perform is broad and includes, but is not limited to, the following categories.
Transporter Assays
Conducts transporter analysis to assess the transport mechanisms and impacts of drugs in the body.
Drug Screening
Screens potential drug candidates to evaluate their activity and feasibility.
Drug Metabolism and Pharmacokinetics
Studies drug metabolism and pharmacokinetics to understand the metabolic and kinetic properties of drugs in the body and the absorption, distribution, metabolism, and excretion properties of drugs in the body.
Analytical and Bioanalytical Assay Development and Validation
Develops and validates analytical and bioanalytical methods to ensure accurate measurement of drugs and biomarkers.
Safety Assessment
Assesses the effects of drugs on cardiovascular, respiratory, central nervous system functions, and potential adverse reactions.
Formulation Analysis
Analyzes the stability and suitability of drug formulations.
Immunogenicity Testing
Assesses whether drugs induce an immune response.
Toxicology Assessment
Screens drug candidates for potential toxicity and evaluates the potential toxic effects of long-term drug administration.
Our Advantages
Professional Team
Advanced Technology
Comprehensive Services
Reliable Data and Results
Protheragen intends to propel the market for therapeutics dealing with mitochondrial diseases with our IND-enabling programs. Our staff’s professional competencies alongside our commitment to carrying out scientific work allow us to offer unparalleled services to our clients who require IND-enabling services. If you have any inquiries regarding our IND programs service or wish to discuss potential collaborations, please do not hesitate to contact us.
