In Vivo Safety Pharmacology

As a leading service provider in the field of cancer immunotherapy discovery and development, Creative Biolabs is fully competent and dedicated to providing a suite of independent or integrated services throughout the life cycle of drug discovery and development.

Focusing on detecting and investigating potential undesirable pharmacodynamic properties on physiological functions of drug candidate exposed in the therapeutic range and above, safety pharmacology is an important step to detect mechanistic effects and evaluate potential adverse effects on various organ systems.

ICH S7A & S7B Guidelines-Compliant Safety Pharmacology

With decades of experience and best-in-class expertise in cancer immunotherapy and drug discovery and development, we offer comprehensive, global and harmonized safety pharmacology studies to facilitate your project in compliance with International Conference on Harmonization (ICH) S7A/B guidelines, thus advancing your program successfully. Creative Biolabs is active in the field of immunotherapy and is innovating the safety pharmacology programs to help effective decision-making in pre-clinical development.

▶ ICH Core Battery Tests (primary organ systems): To assess the acute and potentially life-threatening risks.

• Central nervous system studies: we offer functional observation battery models (FOB) to detect the effects of specific animal models on behavior, locomotion, and coordination.
• Cardiovascular system studies: we provide radio telemetry models to conduct heart rate, electrocardiograms (ECGs), blood pressure, body temperature, echocardiography hERG, and left ventricular pressure assays.
• Respiratory system studies: we have plethysmograph models to facilitate respiratory rate, hemoglobin oxygen saturation and tidal/minute volumes testing.

▶ Supplemental Tests (secondary organ systems): To assess the potential adverse effects on other organ systems, and develop the mechanism of action on vital functions.

• Gastrointestinal system studies: we offer motility and function related studies.
• Renal/Urinary system studies: we offer renal function and general clinical chemistry studies.
• Tier II Assessments: we offer cardiovascular system, cardiac output/arterial flow, vascular/peripheral resistance, and central nervous system (CNS) and respiratory system assessments.

Fig.1 The services we can provide for safety pharmacology.

Our Objectives

• To protect the enrolled volunteers and patients from acute adverse effects;
• To reduce risks of failure due to undesirable pharmacodynamic properties;
• To identify unsafe drug candidates at the lowest possible cost.

Highlights

• Around 100 studies completed every year;
• With a globally advanced platform empowered with various technologies;
• An integrated and multi-disciplinary approach.

Creative Biolabs is committed to providing end-to-end safety pharmacological services to ensure your drug candidates be compliance with ICH guidelines to meet regulatory requirements. Our multi-disciplinary team continuously focus on cancer immunotherapy, which allows us to provide cost-effective drug discovery and development solutions tailored to meet the specific needs and demanding deadline of our clients. If you want to have a further communication or any other requests, please feel free to contact us.