Pre-IND and IND Consulting
The period prior to submission of an investigational new drug application to the FDA is a critical one. We can introduce a company to development concepts such as:
- Critically assessing compound SAR, their drug-likeness, their reactivity, their potential for off-target effects
- Developing a regulatory strategy for submission to the FD and EMA
- Testing a lead molecule in various in vitro assays like hERG, CYP450 isoforms, and metabolite ID
- Performing Ames/mutagenicity assays
- Determining a pharmacokinetic/pharmacodynamic profile of the IND candidate
- Rounding out the in vivo ADME/PK/toxicology profile in various relevant animal models
- Developing supportive bioanalytical methods in various matrices, such as blood, plasma, urine, etc.
- Scaling up from a bench top synthesis (mg/g) to kilogram quantities
- Optimizing and validating analytical methods pursuant to release specifications
- Conducting physicochemical determinations, polymorph characterization, and benchtop stability
- Developing and optimizing a clinical/commercial product formulation
- Planning and initiating a stability program (RT and accelerated conditions)
All of this work maps into a pre-IND meeting package and ultimately the IND’s sections for pharmacology, pharmacokinetics, metabolism, toxicology, and chemistry manufacturing controls.
InClinica orchestrates this work through its strong project management staff, its network of laboratories and manufacturing partners to perform the necessary studies, and its medical writing and quality assurance staff to prepare and review regulatory submissions.
Let us help you lay the groundwork that will increase your chances of moving your molecule or compound successfully toward Phase I or First-in-Man studies.