GLP Research Unit – Contact

    Tell us what you need and we will tailor our offer to your needs! Once we receive your message, we will contact you to arrange the details.

    IN VIVO AND IN VITRO STUDIES:

    Choose what type of study you are interested in?

    1. Individual study protocol – write what you need and we will contact you to discuss the details.

    2. Medicinal products and chemicals:

      Toxic property tests are an essential tool for verifying the safety of developed compounds and chemicals. All institutions marketing innovative products such as chemicals and their mixtures, medicinal products, veterinary medicinal products, plant protection products, food additives, feed additives, cosmetic products (in vitro testing), biocidal products, detergents and other chemicals regulated by the law on chemicals and their mixtures are required to perform them.

      Scope of exposure

      Test system

      Type of study

      Type of research method

      ACUTE TOXICITY

      in vitro

      CYTOTOXICITY

      NRU Yes

      MTT Yes

      XTT Yes

      Direct-contact Yes

      Test on extracts Yes

      Agar diffusion Yes

      IRRITATION

      In vitro reconstructed human epidermis test method; OECD No. 439 Yes

      SENSITIZATION

      Skin Sensitisation; OECD No. 406 Yes

      PHOTOTOXICITY

      In Vitro 3T3 NRU Phototoxicity Test; OECD No. 432 Yes

      in vivo

      TOXICITY

      Acute Oral Toxicity - Fixed Dose Procedure; OECD Nr 420 Yes

      Acute Inhalation Toxicity; OECD No. 403 Yes

      SUBACUTE TOXICITY

      in vivo

      TOXICITY

      Repeated Dose 28-day Oral Toxicity Study in Rodents; OECD No. 407 Yes

      SUBCHRONIC TOXICITY

      in vivo

      TOXICITY

      Repeated Dose 90-Day Oral Toxicity Study in Rodents; OECD No. 408 Yes

      CHRONIC TOXICITY

      in vivo

      TOXICITY

      Chronic Toxicity Studies; OECD No. 452 Yes

    3. Medical devices:

      Biological evaluation tests for medical devices based on standards from the PN/EN ISO-10993 group are among the tests whose main purpose is to analyze the risk of using the developed medicl device in humans. The scope of tests to be performed for a meical device is strictly defined by the first part of the 10993 standard, i.e. 10993-1:2018.

      Category of body contact

      Nature of body contact

      Contact duration

      - A – limited (less than 24H),

      - B – prolonged (to 30 days),

      - C – long term (more than 30 days)

      Cytotoxicity (10993-5)

      Sensitization (10993-23)

      Irritation (10993-10)

      Acute toxicity(10993-11)

      Subacute toxicity (10993-11)

      Subchronic toxicity (10993-11)

      Chronic toxicity (10993-11)

      Local effects after implantation (10993-6)

      Genotoxicity (10993-3)

      Surface medical devices

      Intact skin

      A

      Yes

      Yes

      Yes

      B

      Yes

      Yes

      Yes

      C

      Yes

      Yes

      Yes

      Mucosal membrane

      A

      Yes

      Yes

      Yes

      Yes

      B

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      C

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Breached or compromised surface

      A

      Yes

      Yes

      Yes

      Yes

      B

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      C

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Externally communicating medical devices

      Blood path, indirect

      A

      Yes

      Yes

      Yes

      Yes

      B

      Yes

      Yes

      Yes

      Yes

      Yes

      C

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Tissue/bone/dentin

      A

      Yes

      Yes

      Yes

      Yes

      B

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      C

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Circulating blood

      A

      Yes

      Yes

      Yes

      Yes

      Yes

      B

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      C

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Implant medical device

      Tissue/bone

      A

      Yes

      Yes

      Yes

      Yes

      B

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      C

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Blood

      A

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      B

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      C

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

    4. Good Laboratory Practice certificate:

      Study with certificate of compliance with Good Laboratory Practice Yes

      Study without certificate of compliance with Good Laboratory Practice Yes

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      This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

      I consent to the processing of my personal data by Śląski Park Technologii Medycznych Kardio-Med Silesia Sp. z o.o., 10C M. Curie-Skłodowskiej St., 41-800 Zabrze, KRS:0000396540, NIP:6482761515, Regon:242742607, as Data Controler in order to receive a response. I can withdraw my consent by submitting a statement to: iod@kmptm.pl. The Data Controler has notified me that this consent does not affect the legality of the processing carried out on the basis of consent before its withdrawal.

      The information clause on the details of the processing is available here.

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