The preclinical programs essential for a successful investigational new drug (IND) application necessitate substantial time and resources. Protheragen possesses the expertise and bioanalytical capacity to efficiently provide regulatory-compliant pharmacokinetic, pharmacodynamic, biomarker, and immunogenicity data through our IND program services for mitochondrial disease.
What is IND Program?
The purpose of IND-enabling studies is to obtain approval for conducting first-in-human clinical trials with a novel drug. An IND application encompasses comprehensive information on pharmacology and toxicology, manufacturing aspects (e.g., composition, production, stability), human clinical study protocols, and investigator details.
Why is an IND application required?
Investigational New Drug (IND) application is utilized to assess the acceptability of a new drug's efficacy and safety profile, proposed manufacturing process, and clinical trial designs for conducting studies in humans.
Our Services
Together with our extensive and unparalleled range of services and industry-leading expertise in mitochondrial disease, we assist clients in successfully developing, launching, and completing their IND-enabling programs within specified timelines and allocated budgets. We collaborate closely with clients to customize each exploratory IND-enabling study program based on the specific drug type, intended route of administration, and clinical indication. The services we provide encompass, but are not restricted 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
The mission of Protheragen is to advance the field of mitochondrial disease therapeutics through our specialized preclinical IND programs. Our integrated approach, highly experienced team, and unwavering commitment to scientific excellence enable us to provide exceptional IND-enabling services to our esteemed clients. If you have any inquiries regarding our IND programs service or wish to discuss potential collaborations, please do not hesitate to contact us.
