Rodent PK Study

Rodent PK studies are favored for their lower demand for compounds, shorter TAT at a lower cost, diverse animal models, and mature in vivo technique. There are many types of rodent PK studies that can meet new drug discovery and development needs in preclinical stage and provide reference and guidance for large animal PK studies, pharmacodynamics studies, and toxicology studies.

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Overview
Assays
Animal Species
Route of Administration
Surgical Models
Experience
Facilities
FAQs
Related Resources
Related Services

In Vivo PK

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Overview

Our team has developed more than 30 routes of administration and more than 10 surgery models based on market needs and provides high-quality rodent in vivo PK services to thousands of customers worldwide. The team has also established many unique technical capabilities, such as intravenous infusion for more than 7 consecutive days. The team has launched many high-quality capabilities for the transdermal PK, respiratory PK, ophthalmology PK, and neuro PK and provided many trouble-shooting solutions for customer studies.

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Assays

Hit to lead
- Fast PK:
  Rat and mouse PK (oral or intravenous administration), single or cassette dosing
Lead optimization
- - PK study in rats and mice (administered through oral, intravenous, subcutaneous, intramuscular, and intraperitoneal routes).
  - Single or multiple doses
  - Exposure studies with different formulation
Preclinical candidate (PCC)
- - Single-dose or multiple-dose experiment following specific administration route
  - PK experiments with different salt forms or crystal forms
  - PK experiments with different dosage forms, including bridging studies with clinical formulations
  - Maximum tolerated dose experiment (MTD) and dose escalation experiment
Investigational New Drug (IND) application
- - PK studies of single-dose and single intravenous administration
  - Oral administration PK studies with high, medium, and low doses
  - PK studies of medium dose and multiple oral administration
  - Tissue distribution studies after a single oral administration
  - Biliary excretion studies with medium dose and single oral administration
  - Urine and fecal excretion studies with medium dose and oral administration
  - Identify major metabolites in plasma and excretion

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Animal Species

Mice
- ICR (CD-1)
- C57BL/6
- BALB/c
- FVB
- BALB/c Nude
- NOD SCID
- P-gp/BCRP KO Mouse
Rat
- Sprague Dawley
- Wistar Han
- Wistar
- Brown Norway
- F344(CDF)
- Lewis
Hamster
- LVG Golden Syrian Hamster
Guinea Pig
- Harley Guinea Pig

Route of Administration

Case Sharing of Administration Route

Route of Administration
Case Sharing of Administration Route

- Capsule administration
- Intrathecal injection
- 7-day continuous intravenous infusion
- Intranasal administration
- Intratracheal administration
- Inhalation administration
- Mini-pump implant
- Intravitreal injection
- Intracerebroventricular administration
- Intravenous bolus injection
- Intravenous Infusion
- Oral gavage
- Intramuscular injection
- Subcutaneous injection
- Intradermal injection
- Intraperitoneal injection
- Intestinal administration
- Sublingual administration
- Transdermal administration
- Eye drop administration
- Intra-articular injection
- Rectal administration
- Vaginal administration
- Intravesical administration
Rodent PK Study Part Ⅰ Route of Administration
The transdermal drug delivery system (TDDS) has always been an attractive field as it can provide a therapeutic window larger than whole-body delivery. Topical skin formulations are widely used for topical administration, exert local effects, and cause systemic effects through skin absorption. Methods of evaluating topical drug transdermal delivery are divided into in vivo and in vitro ¹. Skin absorption is mainly a passive diffusion process. Literature has proven that the data obtained from in vitro studies complying with the appropriate protocol are of great reference values. Compared with traditional in vivo experiments, in vitro methods can measure the drug concentration retained in the skin and the amount that diffused through the skin into the receptor chamber. This method allows the exploration of skin permeability at the early screening stage. No live animals are used in this study, and multiple replicates can be applied at the same or different compounds. This feature is especially suitable for comparing the skin penetration of the same compounds in various in vivo studies complying with the appropriate protocol are of great reference values. Compared with traditional in vitro formulations and screening the transdermal properties of different compounds ² In vitro, transdermal experiments tested the drug permeability of different batches of drugs using Bama minipigs' skin. The data showed no significant difference in the in vitro permeation characteristics between the test and the reference.
- 24h Permeation Profile using Bama Miniature Pig Skin
  
  Figure 1
- 24h Permeation Profile using Bama Miniature Pig Skin
  
  Figure 2
- 24h Skin Retention of a Drug in Bama Miniature Pigs' Skin
  
  Figure 3
- Permeation Flux Reached Steady State using
  
  Figure 4

Surgical Models

Case Sharing of Surgical Model

Surgical Models
Case Sharing of Surgical Model

- Vascular Cannulation
  - Carotid
  - HJugular vein
  - Femoral artery
  - Femoral vein
  - Hepatic portal vein
- Non-vascular Cannulation
  - Bile duct
  - Duodenum
  - Mesenteric lymph
  - Cisterna magna cannulation
- Non-survival Surgery
  - In situ small intestine perfusion
  - Isolated liver perfusion
  - In situ brain perfusion
  - Nasal lavage
  - Bronchoalveolar lavage
Rodent PK Study Part Ⅱ Surgical Models

In situ single-pass intestinal perfusion (SPIP) model: To date, the most used model for predicting the absorption process in humans is the Caco-2 cell monolayer system. While drug permeability correlates well with drug absorption in humans and the Caco-2 studies, there are many limitations when studying carrier-mediated transport or monitoring intestinal metabolites ³. In situ single-pass intestinal perfusion (SPIP) is the closest experimental method that mimics oral administration and directly measures compound absorption rate. The intestinal structure is similar in both humans and rodents, and there is a strong correlation between effective permeability (P_eff) and fraction absorbed (F_a) between these two species (R² = 0.8 to 0.95). It is easy to control the intestinal environment in SPIP studies, such as drug concentration in the perfusate, perfusate pH, perfusion flow rate, and target intestine perfusion part of the study. More importantly, the SPIP enables simultaneous measurement of the effective permeability (P_eff) and flux of drugs appearing in mesenteric blood (P_app) ⁴^{, 5}. The team can use SPIP models in rodents to assess the intestinal permeability of test compounds and monitor their metabolites.

Group	Test Compound	P_eff from Literature (×10^-6 cm/s)⁶^,7	P_eff from Verification Studies (×10^-6cm/s)	Average P_app (×10^-6 cm/s)
High Permeability	Carbamazepine Propranolol Metoprolol	62-160 41-69 14.3-50.2	85.60±20.54 59.69±7.31 23.71±0.92	34.18±14.47 34.47±6.48 1.51±0.03
Medium Permeability	Ranitidine Dexamethasone Atenolol	14.7-30 16-24 1.8-16	16.84±3.79 17.79±6.39 3.46±1.20	13.77±6.64 3.82±0.82 3.15±1.36
Low Permeability	Topotecan Nadolol	1.7-55.8 2.7-5.3	1.70±2.91 3.52±8.89	11.49±1.46 3.22±2.72

Group

Test Compound

P_eff from Literature

(×10^-6 cm/s)⁶^,7

P_eff from

Verification Studies

(×10^-6cm/s)

Average P_app

(×10^-6 cm/s)

High

Permeability

Carbamazepine
Propranolol
Metoprolol

62-160
41-69
14.3-50.2

85.60±20.54
59.69±7.31
23.71±0.92

34.18±14.47
34.47±6.48
1.51±0.03

Medium

Permeability

Ranitidine
Dexamethasone
Atenolol

14.7-30
16-24
1.8-16

16.84±3.79
17.79±6.39
3.46±1.20

13.77±6.64
3.82±0.82
3.15±1.36

Low

Permeability

Topotecan
Nadolol

1.7-55.8
2.7-5.3

1.70±2.91
3.52±8.89

11.49±1.46
3.22±2.72

List of biological sample collection of rodents

List of Organ and Tissue Matrix for histopathology

Whole blood
Plasma
Serum
White blood cell
Erythrocytes
PBMC
Ocular tissues*
Brain tissue* *
Bone marrow
Organs
Intestinal fluid
Gastric fluid
Bronchoalveolar lavage fluid
Joint lavage fluid
Nasal mucosa
Cerebrospinal fluid
Cerebrospinal fluid (rat multiple consecutive)
Lymph (surgical)
Bile (surgical)
Urine (metabolic cage)
Feces (metabolic cage)
Intestinal perfusion (rat, surgical)
Liver perfusion (rat, surgical)

The samples of ocular tissues include but are not limited to conjunctiva, cornea, iris, lens, ciliary body, retina, choroid, sclera, optic nerve, aqueous humor, vitreous body, and tear.

Samples of various brain tissues include but are not limited to the caudate nucleus, cerebellum, cerebral cortex, white matter of the cerebrum, cingulate gyrus, cingulate sulcus, corpus callosum, external capsule, internal capsule, globus pallidus, hippocampus, hypothalamus, pituitary gland, midbrain, medulla oblongata, optic nerve, optic chiasm, pons, shell, and spinal cord.

Rodent PK Study Part Ⅲ List of Organ and Tissue Matrix for histopathology

Experience

18+

Years of experience
280+/Year

Rodent IND PK studies
10,000+/Year

Rodent discovery PK studies

Facilities

There are 3 facilities for rodent PK studies, which are located in Shanghai, Suzhou, and Nanjing respectively. All animal facilities are barrier systems and are accredited by AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care) International. In addition, the Shanghai and Suzhou animal facilities also have the US OLAW Animal Welfare Assurance. The main SPF animals in the facility include rats, mice, guinea pigs, and hamsters, and can support the PK study throughput of 2,200 animals/week.

AAALAC Certificate
Surgery Room
Automated Blood Sampler (ABS)
Pulse Vacuum Steam Sterilizer
Corridor
Cage and Rack washer

Learn more about our facilities

Including mouse，rat，hamster，monkey，dog，pig，rabbit，etc

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FAQs

What is a Rodent PK study?

Rodent pharmacokinetic (PK) studies evaluate and elucidate the mechanism of absorption, distribution, metabolism, and excretion of test articles in rodents, such as mice, rats, etc. These studies are crucial for determining appropriate drug exposure, dose requirements, and other PK parameters to facilitate efficacious and safe studies in the future.
What types of rodents are commonly used in PK studies?

In rodent PK studies, the most commonly used animals are mice and rats, followed by hamsters and guinea pigs.
What are your capabilities in rodents for neuro PK?

We have a lot of experience with neuro PK studies in rodents, and we can perform intracerebroventricular administration and we can collect cerebrospinal fluid in rats and mice and different brain tissues in rodents as well.
What are your advantages in respiratory drug delivery for rodents?

We have rich experience in rodent respiratory drug administration, such as intranasal administration, intratracheal administration, inhalation administration, etc. We have also provided a lot of high-quality study services to customers.

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Browse All Rodent PK Study Resources

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References

1.
Guideline, O. E. C. D. 428-Guideline for the Testing of Chemicals-Skin Absorption: in vitro Method." Organization for Economic Cooperation and Development, Paris (2004)
2.
Oh, Luke, et al. In Vitro Skin Permeation Methodology for Over-The-Counter Topical Dermatologic Products." Therapeutic Innovation & regulatory science 54.3 (2020): 693-700
3.
Kim, J.S., Mitchell, S., Kijek, P., Tsume, Y., Hilfinger, J. and Amidon, G.L., 2006. The suitability of an in-situ perfusion model for permeability determinations: utility for BCS class I biowaiver requests. Molecular Pharmaceutics, 3 (6), pp.686-694
4.
Chiou, W.L. and Barve, A., 1998. Linear correlation of the fraction of oral dose absorbed of 64 drugs between humans and rats. Pharmaceutical Research, 15 (11), p.1792
5.
Cao, X., Gibbs, S.T., Fang, L., Miller, H.A., Landowski, C.P., Shin, H.C., Lennernas, H., Zhong, Y., Amidon, G.L., Lawrence, X.Y. and Sun, D., 2006. Why is it challenging to predict intestinal drug absorption and oral bioavailability in humans using the rat model. Pharmaceutical Research, 23 (8), pp.1675-1686
6.
Salphati, L., Childers, K., Pan, L., Tsutsui, K. and Takahashi, L., 2001. Evaluation of a single-pass intestinal perfusion method in rats for the prediction of absorption in man. Journal of pharmacy and pharmacology, 53 (7), pp.1007-1013
7.
Dahlgren, D., Roos, C., Sjögren, E. and Lennernäs, H., 2015. Direct in vivo human intestinal permeability (Peff) determination with different clinical perfusion and intubation methods. Journal of pharmaceutical sciences, 104 (9), pp.2702-2726

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Rodent PK Study

Overview

Assays

Hit to lead

Lead optimization

Preclinical candidate (PCC)

Investigational New Drug (IND) application

Animal Species

Mice

Rat

Hamster

Guinea Pig

Route of Administration

Case Sharing of Administration Route

Surgical Models

Case Sharing of Surgical Model

List of biological sample collection of rodents

Experience

Facilities

Learn more about our facilities

FAQs

What is a Rodent PK study?

What types of rodents are commonly used in PK studies?

What are your capabilities in rodents for neuro PK?

What are your advantages in respiratory drug delivery for rodents?

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