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Small Molecules

A small molecule in a big world.

Small molecule drugs are defined as chemically synthetic or naturally-derived drugs with low molecular weight. From analgesics to anti-infectives and to cardiovascular, central nervous system, and oncology medicines, small molecules have proven successful for a broad range of indications. For the development of novel small molecules, careful consideration is required to select the appropriate drug development path towards the clinic. Our in-house experts and Program Managers, in conjunction with our vast network of regulatory and subject matter experts, can help you tailor the right program with the clinical end in mind.

small molecule challenges

Unique Challenges within a Small Molecule Preclinical Program Development.

  • A major challenge of working with small molecules is their tendency to be poorly soluble and bioavailable. Solving this early in the drug development process can increase the odds of a successful program.
  • Drug metabolites should be identified and tracked using appropriately qualified or validated analytical methods. In some situations, they should be evaluated independently.
  • Off-target toxicity is often observed with small molecules; designing the study with the right doses, evaluations, and recovery times is critical to assess safety properly.
  • Strategizing timing between the studies in a program should be done to achieve multiple purposes, from allowing informed decision-making for the dosing of a follow-up study to enabling fundraising cycles and timely regulatory filing.
  • Preclinical study reporting is not a trivial process. Ensuring that the information is clear and in context to the small molecule and its application requires careful consideration and a clear understanding of the data.
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KreaMedica’s Solutions

  • Having worked on many small molecule programs, KreaMedica can help you design the right program to achieve your objectives while maintaining scientific integrity and keeping your budget in mind.
  • We have extensive in-house experience and a network of qualified vendors in assay development, analytical method development, and preclinical toxicology. From metabolite identification to assay development, we have the capabilities, expertise, and experience to meet your needs.
  • We can help you identify the relevant non-rodent and rodent species that most accurately represent what you can expect in the clinic.
  • We design your studies with the final results in mind and efficiently use your budget.
  • We strive to understand your needs as a company and the needs of your preclinical program. With our in-house toxicology, assay development, and scientific and program management expertise, we can help you back-engineer your preclinical program strategy to achieve your company’s milestones.
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