A preclinical study determines a drug efficacy and safety and assesses potential toxicity before testing it in humans. Typically, both in vitro and in vivo studies are performed, and these studies must provide detailed information on dosing and toxicity levels required by FDA.
Successful preclinical studies demand experienced experts in toxicology, pathology, surgery and other related fields. CD BioSciences offers a complete package of preclinical services to efficiently assess your drug's potential and guide you throughout all phases of the preclinical study including filing the Investigational New Drug (IND) application.
We support the evaluation of therapeutics of multiple forms, including antibodies, recombinant proteins, peptides, small molecules, cell therapy of CAR-T, and oncolytic viruses. As your single-source provider of comprehensive preclinical services, we develop personalized plans to meet all your needs.
Our service includes but is not limited to the following.
In vitro and in vivo ADME, pharmacokinetics and bioanalysis assays to characterize the Absorption/Administration, Distribution, Metabolism, and Elimination/Excretion (ADME) properties of drugs.
- Aqueous Solubility
- Absorption and Bioavailability
- Metabolite Profiling
- Protein Binding
- Tissue Distribution
- Metabolic Stability
Pharmacological Efficacy Test with Animal Models
A variety of effective animal models with a wide coverage of diseases to detect drug efficacy.
- Digestive System Models
- Orthotopic Models
- Syngeneic Mouse Models
- Neurological Disorders Models
- Inflammation & Immunological Disease Models (Arthritis, Dermatitis, Diabetes, Fibrosis, Lupus, Pruritus and Psoriasis)
- Cardiovascular Disease Models (Hypertension and Thrombosis)
- Metabolic Disease Models (Diabetes (Type I and II), NASH, Obesity and Pancreatitis)
- Tumor Xenograft Models
- Cell Line Derived Xenograft (CDX) Models
- Patient Derived Xenograft (PDX) Models
- Other Disease Models
Toxicological evaluations ranging from dose design, in-life studies to histology and pathology testing along with toxicokinetic studies to identify the most valuable drug candidates.
- Single Dose Toxicity Test
- Repeated Dose Toxicity Test
- Maximum Tolerated Dose Test (Dose Range Finding)
- Genotoxicity Test
- Toxicokinetic Test
- Partial Toxicity Test
- Side-effect Profiling
- Pain Assessment (acute, inflammatory, neuropathic and translational)
- Central Nervous System Function
- Cardiovascular Function
- Respiratory Function
- Autonomic Nervous System Function
- Endocrine and Metabolic Effect
- Immune Effect
- Gastrointestinal and Renal Function (gastric acidity, irritation, ulceration and motility)
- Reproductive System Function
CD BioSciences is experienced to conduct preclinical studies in a wide array of species, such as Mouse, Rat, Dog, NHP(Monkey), Rabbit, and Guinea Pig. And we offer multiple routes of administration including Oral (gavage, diet, capsule), Parenteral (intravenous, subcutaneous, intramuscular, intraperitoneal, intrathecal and intra-articular), Infusion, Ocular, Intranasal, Topical, Intravaginal, and Rectal.
Advantages of Our Preclinical Services
As a trusted service provider for decades, we are equipped with advanced platforms and highly experienced scientists dedicated to supporting you at every step of your drug discovery and development processes.
With our high-tech platforms, we offer comprehensive preclinical services to cover both pharmacological and toxicological profiling of the drugs.
We provide a full set of drug-based solutions from drug discovery to preclinical study to meet your need with high quality and integrity.
CD BioSciences offers cost-effect, high quality and hassle-free preclinical services to our clients worldwide. We guarantee to deliver our results on time. Please feel free to contact us.
For research use only. Not intended for any clinical use.