PK Services: Animal Facility Routes of Administration

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PK Services

Animal Facility GVK BIO vivarium is AAALAC certified and registered with CPCSEA (Committee for the Purpose of Control and Supervision of Experiments on Animals), Government of India. In our rodent facilities, animals are housed in Individual Ventilated Cages (IVC) in controlled temperature (22 -25C) & relative humidity (30%-70%) maintained at 12 h/12 h light/dark cycle. In Vivo Pharmacokinetics Rats of different strains- Sprague Dawley(SD), Wistar, Wistar Han and Lewis Mice of different strains - Swiss albino, BALB/c, C57BL/6, CD-1, Nude mice, etc. Hamster and Guinea pigs Discrete/Serial/Drug- Drug Interaction Rapid PK/Snapshot PK/Cassette PK Absolute Bioavailability Capabilities to conduct PK/PD relationship studies Blood sample collection techniques retro-orbital / cardiac puncture/tail vein and jugular vein In Vivo Blood Brain Barrier(BBB) study Tissue Distribution studies Specialized studies for enterohepatic/first pass effect Ex vivo protein binding studies to measure free/bound drug and unbound drug in plasma, brain and CSF Ex vivo tissue permeability studies -Franz Diffusion assay (PermeGear) Biliary excretion studies Toxicokinetic studies Perfusion capabilities Cannulation/Surgical Procedures Jugular vein cannulation Portal vein cannulation Bile duct cannulation Femoral vein cannulation Double cannulation (jugular and femoral) Double cannulation (jugular and portal, jugular and bile duct Carotid artery cannulation Ovarectomy Adrenalectomy Routes of Administration Oral - Solution, Suspension, Solids (pellets, capsules) Intravenous - Bolus, Infusion Intraperitoneal Subcutaneous Intramuscular Dermal Intratracheal Buccal/Sublingual Intraduodenal Intracolonic Intranasal Type of PK Studies Single Dose Multiple Dose Dose Linearity Tissue Distribution Alternate Dosing Drug-Drug Interaction Studies Fed/Fast PK BBB BBB & CSF Topical PK Infusion Studies Cassette PK Biological Fluid/Organ Collection Blood Urine CSF (Rat) BAL Bile All organs (brain, lungs, heart, lymphnode, salivary gland, ovary, spleen, skin, muscle, adrenals, kidney, fat tissue, thymus etc.)

We provide flexibility in protocol development, quality data and rapid turnaround time to our clients.

PK Services
Bio-analysis Analysis by LC-MS/MS/HPLC-UV/PDA/ Fluorimetry/ Spectrophotometer Method Development and Validation in Biological Matrices such as Blood, Plasma/Serum, CSF and Tissue homogenates PK analysis by Watson LIMS Quantification of Parent and Metabolites, Cassette Analysis, Cell Culture Measurement of Parent and Prodrug

Typical study design for In Vivo PK/Bio-analysis Report delivery within seven working days
Animal Administration Route Protocol Blood/Tissue samples collected at scheduled time points post dosing, plasma separated and analyzed for test item concentration Parameters Data Analysis

Mice/Rats (N=3/group)

p.o.,i.v., i.p., s.c., i.m. infusion

Cmax, Tmax, AUC, clearance, terminal elimination half life, bioavailiability and volume of distribution

WinNonlin Software

60000

AUC (ng.hr/g)

50000 40000 30000 20000 10000 0

c c BBB BBB CSF CSF study of test compound in SD rat at 10 mg/kg following oral administration.
Adrenal Blood Brain Heart Fat Lung Liver Kidney Lymph Salivary Pancreas Testis Muscle Spleen

Tissuedistribution distribution profile the Test compound in Wistar Tissue profile of of the test compound in Wistar rat Rats

BBB CSF study of test compound in SD rat at 10 mg/kg following oral BBB-CSF study of Test compound in SD Rats (10 mg/kg) following oral administration.

c BBB CSF study of test compound in SD rat at 10 mg/kg f ollowing oral administration. 750

Concentration (ng/mL)

c BBB CSF study of test compound in SD rat at 10 mg/kg following oral c BBB CSF study of test compound in SD rat at 10 mg/kg following oral administration. administration.
Prodrug Drug 500 250 0 0 0.1 0.2 Time (hr) 0.3

Bioavailability Test compound male SD Rats after intravenous (1mg/kg) Bioavailability ofof compound in malein Sprague Dawley rat after intravenous (1mg/kg) and administration andoral oral(5mg/kg) (5mg/kg) administration.

The pharmacokinetic profile Prodrug and parent compound in blood inmale maleWistar Wistar rat Pharmacokinetic profile of of Prodrug and Parent compound in blood in after intraportal administration of Prodrug at a dose of 3 mg/kg Rats after intraportal administration of Prodrug (3 mg/kg)

About GVK BIO


GVK Biosciences (GVK BIO) is Asias leading Discovery Research and Development organization. GVK BIO provides a broad spectrum of services, stand-alone and integrated, across the R&D value chain. Chemistry Services Process R&D and Custom Synthesis Biology Informatics Clinical Research Clinical Pharmacology

Contact: bdbio@gvkbio.com

Visit: www.gvkbio.com

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