Pharmacokinetics

ChemPartner has conducted 120-150 PK studies per week and served many pharmacokinetics (PK) clients.

• AAALAC and OLAW accredited animal facilities with access to broad ranges of animal species
• State-of-the-art instruments
• Extensive experience in PK model development with comprehensive in vivo techniques such as surgical operation and animal care
• Formulation support for in vivo studies including formulation screening, development, and formulation recommendation for various species and strains
• PK/PD data analysis, modeling, and simulation
• Regulatory filing support

 

Animal Species

• Mouse, rat, guinea pig, rabbit, dog, monkey, and mini pig

 

Dose Route

• Conventional administration routes: IV, PO (capsule & tablet, etc.), SC, IP, IM, topical administration
• Special Clinical or Research Application: IV infusion, SC infusion, intranasal (IN), rectal, retro-orbital injection, intravitreal injection, intrathecal injection
• Advanced methods: AZ pump, intracerebroventricular (ICV), intratracheal (IT)

 

Sampling

• Venous: Tail vein, jugular vein, facial vein and submandibular
• Cerebrospinal fluid (CSF): Cisternae magna puncture, spinal cord puncture
• Bodily fluids/samples: Tear collection, lymph collection, urine collection, feces collection
• In-life tissue biopsy: Adipose, muscle, liver, kidneys, etc.
• Brain region-specific sampling
• Intraocular region sampling

 

Comprehensive Surgical Techniques

• Portal vein cannulation
• Mesenteric lymph duct cannulation
• Bile duct cannulation (mouse, rat, dog, and monkey)
• Enteral administration (duodenum, jejunum, ileum, colon, rectum)
• Terminal CSF collection (mice) and survival CSF collection (rat, mini pigs, dog, and monkey)

 

Biological Matrix

• Blood, plasma, urine, tissue, CSF, brain, sciatic nerve, DRG, lymph node, bone marrow and all other tissues.

 

Pre-formulation Development

• Physicochemical characterization
  

  • Polarized light microscopy
  • DSC &TGA
  • XRPD
  • DVS
  • PSD
  • logD, logP, pKa
  • Thermodynamic solubility
  • Solution/suspension stability
  • Solid state property
  • Dissolution test

• Salt screening
• Polymorph screening
• Ball milling
• Solid dispersion screening and spray drying

 

Formulation Development

• Clear solution strategy for IV dosing
• Suspension formulation strategy for chronic toxicity study
• Simulated intestinal fluid (SIF) and simulated gastric fluid (SGF) dilution study for in vivo precipitation and super-saturation prediction
• Advanced formulation approach (microsuspension, nanosuspension or solid dispersion)