Pharmacokinetics.pdf

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)