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In recent years, a variety of outstanding drugs have been withdrawn due to drug safety problems. Almost every withdrawal was due to serious or fatal side effects that were not fully taken into account at the time of approval. Side effects, also known as adverse events, occur in addition to the desired therapeutic effect of a drug, which may vary for each individual affected by age, weight, gender, ethnicity, general health and other factors. Almost all drugs have side effects, but the extent and severity of their effect vary from mild problems such as mild itching or headache to life-threatening events such as heart attack, liver failure, renal damage and allergic reactions.
However, the problems arising from drug side effects did not stop occurring. The importance of drug safety is becoming more and more prominent. Many changing acts, laws or amendments have been created to ensure drug safety before drug efficacy. Therefore, drug safety assessment is a key procedure in drug research and development. Drug side effects must be comprehensively detected in order to reduce the safety risk of drugs after marketing as much as possible.
The aim of drug safety assessment is to determine the time, nature, degree and reversibility of potential toxic target organs and toxic reactions, and to determine the safety parameters of clinical testing. Drug safety assessment is very complex and involves multidisciplinary including chemistry, cell biology, molecular biology, drug metabolism and pharmacokinetics, pharmacodynamics and toxicology.
Creative Biolabs provides powerful risk-based preclinical data verification services for drug research and development to deal with data reproducibility crisis which is a big obstacle for drug research and development and may lead to failure and high risk of investment. Our professional team provides a full range of in vivo and in vitro drug safety assessment services to help our clients make wise choices of their projects and also accelerate drug research and development project. We will work with our clients to develop and execute customized services to ensure that drug safety assessment is conducted in an efficient and low-cost manner.
Safety pharmacology is an essential step in assessing any potential adverse effects and potential life-threatening risks that drug candidates may bring to the main physiological system of the human body and is required before first-in-human drug testing. It aims to protect patients from adverse effects and minimize the risk of drug development failure due to undesirable pharmacodynamic effects. Creative Biolabs with pharmaceutical expertise offers global clients with safety pharmacology services for the safety assessment of new drug candidates in order to guide preclinical in vivo toxicity studies and help design clinical studies.
DMPK is the study of drug disposition process in the organism. It describes the process of absorption, distribution, metabolism and excretion (ADME) using mathematical and dynamic models and combines the exposure of drugs in blood circulation and target organs with clinical manifestations (pharmacodynamics and toxic side effects). A sub-optimal DMPK profile is one of the key reasons for unwanted adverse effects and the failure of potential new therapies in early clinical trials. DMPK is important for the selection of highly developable candidates with good bioavailability and safety. We are specializing in offering comprehensive in vitro and in vivo DMPK studies.
Toxicity assessment poses a crucial part in drug safety profiles, which is the major cause of development termination and withdraw from the market. Toxicology studies are generally required by regulatory agencies worldwide before testing in humans. It is essential to evaluate the toxicology potential of drug candidates at an early stage to save time and resource investment. Creative Biolabs is a leading biological company specialized in new drug research and development and offers global clients with toxicology services to assess drug safety. Our in-house team of scientists designs and performs toxicology studies covering multiple aspects to assess safety of drug candidates as comprehensively as possible. We have a wide range of cell services and animal models to meet all your needs.
Pathology is a significant branch of medical science and a major field in modern medicine and diagnosis. It is the study of the cause and effects of disease and involves the examination of tissues, organs, bodily fluids, and autopsies in order to study and diagnose disease. Pathology plays a critical role in safety assessment of potential drugs. With years of hard work, we can provide a wide array of routine and specialized pathology services to support your project by our pathologists who have years of experience in evaluating potential effects of drug candidates.
Drug-drug interaction (DDI) is defined as the change in efficacy or toxicity of a drug after the use of the second drug. DDI may delay, decrease or enhance drug absorption, increase minor or serious unexpected side effects, or even increase the possible toxicity of a certain drug. Drug-drug interaction may be a pharmacodynamic interaction or a pharmacokinetic interaction. Creative Biolabs has established a full portfolio of assay systems to provide our customers overall information concerning the DDI potential of investigated compounds.
Creative Biolabs is a professional contract research organization with cutting-edge technology platforms and specialized teams consisting of excellent staffs. We have abundant experience in pharmacological projects. Study design and selection of the appropriate models are often customized according to the objectives of each project and all studies are performed under strict guidelines. We can verify key data of your drug research and development projects to help our clients’ make wise decision and reduce investment risk. Our mission is to meet our clients’ goal with superior quality and service. If you are interested in our services, please contact us without any hesitation.