Drug Safety and Metabolism

Experience — from discovery to full development: Ricerca has the know–how
Ricerca Biosciences provides drug safety and metabolism services to guide new therapies from discovery to full development support. Our extensive profile of IND enabling pivotal studies support swift progression of your lead compounds into the clinic — streamlining your development process. We provide the resources of a highly skilled, client–focused staff with extensive academic, scientific and pharmaceutical industry experience.

Core services

IND–enabling studies

  • IND/Study Design
  • Regulatory/general toxicity
    – Maximum tolerated dose
    – Dose range–finding — 5–14 days
    – Repeat dose GLP — 4–13 weeks
    Rodents
    Non Rodents (dogs, NHP, minipig)
    – Complete toxicokinetics/pharmacokinetics support with LC/MS/MS
  • Safety pharmacology: ICH core battery & supplemental safety pharmacology studies
    – CNS, respiratory; renal, GI
  • Full clinical and anatomic pathology, ophthalmology, ECG
  • Pivotal Toxicology

Nonclinical registration

  • Chronic toxicity — 6–9 months
  • Investigative toxicology
  • Carcinogenicity studies

Post IND Services


Safety Pharmacology

Our safety pharmacology studies are designed to determine potential hazards and assist in the prediction of adverse effects. Because pharmacological responses may be unique, we work with you to design customized, detailed protocols for your studies.
  • CNS, respiratory
  • Functional Observational Battery (FOB) and motor activity
  • Supplemental safety pharmacology studies
    – GI, Renal

Metabolism studies

Ricerca’s Drug Metabolism and Pharmacokinetics (DMPK) specialists provide world–class expertise in selecting a testing strategy specific to your development stage and provide high–quality data necessary for intelligent decision making.
Ricerca is accredited by AAALAC International, which promotes the highest standards of animal care in the world.

In vivo metabolism

  • Full PK/PD modeling
  • Metabolite ID & profiling
  • ADME mass balance, tissue distribution
  • Radiochemistry synthesis support

Pharmacokinetics (PK) & Toxicokinetics (TK)

  • Bioavailability
  • Formulation selection
  • Bioequivalence (BE)
  • TK support for single and multiple dose toxicology studies

Expertise with major therapeutic areas

  • Cardiovascular
  • CNS
  • Gastrointestinal
  • Immunology/inflammation
  • Anti–infectives
  • Metabolic/endocrine
  • Oncology (cytotoxic and cytostatic)
  • Pain

Commitment to animal welfare

Ricerca Biosciences is committed to the enhancement of animal health and welfare. We honor an organizational commitment toward the ethical and humane use of laboratory animals, paying particular attention to the housing conditions and environmental enrichment of our animal species.

Other Ricerca services

Chemistry

  • Process chemistry
  • Process development and engineering
  • Analytical chemistry
  • Medicinal chemistry
  • Custom synthesis
  • Radiosynthesis
  • Custom development and validation of analytical methods for bulk pharmaceuticals, impurities and metabolites
  • Physical characterization (particle size, surface area, pore volume, tensile/compression testing, etc.)
  • Stability testing
  • GLP characterization of test and control articles