Creative Biolabs provides all aspects of in vivo pharmacokinetic support and is offered as part of a complete development program, as a full-service package or a stand-alone service. With thoroughly understanding the DMPK of a potential clinical candidate, we provide you interspecies scaling service in drug development program.

In most cases, the pharmacokinetics of drugs in animals differs from that in humans. Thus, to make animal experimentation meaningful, a new drug needs to test several PK parameters from three or more species.

Creative Biolabs provides several animal species for PK assessment, which include:

  • Mice
  • Rats
  • Rabbits
  • Guinea pigs
  • Dogs
  • Mini pigs
  • Non-human primates

We provide interspecies scaling (IS) service by whole-body physiologically-based scaling or by allometric scaling.

Whole-Body Physiological-Based Scaling

Whole-body physiological-based models include several biological subsystems such as blood, the lymphatic and the central nervous system, tissues, and organs. This method is a recommended approach for IS for various administration routes and doses. Our services including but not limited to:

The Administration Routes we provide include:

Oral; Intravenous; Continuous intravenous; Transdermal; Subcutaneous; Intramuscular; Intratracheal; Instillation; Intrarectal & Intraduodenal.

Allometric Scaling

Although physiological-based scaling provides an inherent understanding of drug disposition, it is considered to be a complex, costly, and time-consuming method with frequent failures.

The major premise of allometric scaling is that since many physiologic parameters are a function of the size of animal species, it follows logically that the major PK parameters, such as clearance (CL), the volume of distribution (Vz), and half-life, should also be related to the size of the animal. Creative Biolabs provides the allometric approach for establishing a quantitative relationship between the different pharmacokinetic parameters and the physical characteristics of the various animal species.

Several characters are taken into consideration to build a more reliable model for interspecies scaling. The characters include:

  • Body weight
  • Liver weight
  • Brain weight
  • Body surface area
  • Maximum life span
  • Hepatic blood flow
  • Glomerular filtration
  • Cardiac output

Organ blood flow rates, organ size, tissue-to-blood partitioning, and metabolic chemical reaction rates are used to depict the concentration of drug in blood and the various organs as a function of time. The concentration-time profile in humans is then simulated by differential equations between humans and other animals.

Analytical Methods

We use various analytical methods to evaluate plasma (or whole blood or serum) concentrations of pharmaceuticals with adequate sensitivity and precision. Our validated analytical methods conform to Good Laboratory Practice (GLP). Methods used in such studies include:

  • Gas chromatography
  • HPLC
  • LC
  • LC-MS
  • LC-MS-MS
  • Capillary electrophoresis

For more detailed information, please feel free to contact us or directly sent us an inquiry.

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