Pipeline Biotech DMPK Studies

Introduction

Pipeline Biotech is expert in carrying out comprehensive drug metabolism and pharmacokinetic (DMPK) studies in a wide range of experimental animals, including mice, rats, guinea pigs and rabbits.

These studies can be carried out to GLP standards and used to assess pharmacokinetics, bioavailability, bioequivalence, permeability or any more specialized models needed to select candidate drugs or support regulatory submissions.

DMPK, In-Life phase

Pipeline Biotech can perform in vivo DMPK studies in the following experimental animals sourced from recognized suppliers.

For mice and rats all available strains from the indicated suppliers may be used.Drug metabolism study typesPipeline Biotech’s scientists within pharmacokinetics, bioanalytical chemistry and ADME can design and interpret both in vitro and in vivo components for drug metabolism studies based on client program goals. The laboratory can provide fully validated chromatographic and pharmacokinetic evaluations.Studies can follow any of the following models:

• Pharmacokinetics
• Bioavailability
• Biliary excretion
• Mass balance
• Tissue distribution
• Bioequivalence
• Blood-Brain barrier permeability

More specialized models can also be investigated according to particular client requirements.DMPK methodsPre-Formulation
Pipeline Biotech will carry out any pre-formulation of dose solutions required, according to sponsor’s advice, using laboratory space dedicated to formulation activities.Where formulation information is not readily available, the project team can assist client with investigations of solubility and best choice of vehicle.Dosing methods
Administration can be performed as single or repeated doses or multiple compound cassette dosing.Continuous intravenous infusion or subcutaneous infusion, using Alzet Osmotic pumps, is also available.Administration and catheterizations
Pipeline Biotech’s in vivo studies can use the whole range of drug administration routes, including peroral, intravenous infusion, intraperitoneal, intramuscular, subcutaneous, inhalation via nebulizer, intranasal, intratracheal, topical, intradermal, intra-auricular, intracardial, intracolonic or stereotactic intracranial injection.Catheterizations can be carried out via carotid artery; femoral, jugular or portal veins; or bile duct.SamplesInvestigation can be based on a wide range of samples, including blood, urine, feces, bile or tissue. Samples can be collected by Pipeline Biotech and shipped on dry ice within 24 hours to all major cities in Europe.Isotopic studiesThe Pipeline Biotech laboratory is also equipped to carry out radio isotopic drug metabolism evaluations.Pipeline Biotech offers standard pharmacokinetic studies with radioactive isotopes ³H, ¹⁴C, ³²P, ³⁵S and ¹²⁵I, tracing the test compound with the radioactive isotope to perform detection of peptides and protein-based drugs.Clinical observationsIn all pharmacokinetic investigations, the Pipeline Biotech study team will record all visible signs of ill health and any behavioral changes during the study. They will report any deviation from normal with respect to time of onset, duration and intensity.BioanalysisPipeline Biotech’s core competence and focus is on executing in-life phase services, with many sponsors preferring to perform bioanalysis at their own in house laboratories.For clients that do not have these capabilities at hand, Pipeline Biotech can include professional bioanalytical services performed by selected partner CROs that focus on this discipline.Quality & StandardsPipeline Biotech can carry out DMPK studies to in compliance with Good Laboratory Practice (cGLP) or Non-GLP standards, depending on regulatory requirements.Pipeline Biotech has more than 15 years of experience in performing experimental animal research for the pharmaceutical industry. Laboratory animals are housed at different levels of barrier protection including GMO Class I and Class II and Biohazard Class III. All experiments are performed in accordance with EU-regulations and approved by the Danish Medicines Agency and the National Animal Experiments Inspectorate.ResourcesClick on Pipeline Biotech DMPK studies for other information.
Click on Pipeline Biotech to contact the company directly.Supplier Information
Supplier: Pipeline Biotech A/S
Address: Roevedvej 1, 8380 Trige, Denmark
Tel: + 45 8748 9770
Fax: + 45 8748 9771
Website: www.pipeline-biotech.dk