Maximum Tolerated Dose
Creative Biolas is a pioneer in toxicology services and dedicated to pharmaceutical/biopharmaceutical, biotech, academic research, medical device and related industries. We offer a comprehensive service for preclinical drug safety evaluation. Our services encompass toxicology, pharmacology, oncology, and metabolism testing. We deliver GLP and Non-GLP biological services to our clients in support of their drug development programs.
The maximum tolerated dose (MTD), an important part of preclinical toxicity test, describes the highest dose of a treatment or medicine that will produce the desired effect without causing unacceptable side effects or overt toxicity in a specific period of time. The MTD can be determined by acute toxicity studies, short duration dose escalation studies and dose ranging studies. These studies are designed with a minimum number of animals and include toxicological endpoints such as clinical observations and clinical pathology. Maximum tolerated dose is an essential aspect of a drug's profile. This information obtained from MTD can help guide the parameters for clinical trials to maximize safety and minimize risk. All modern healthcare systems dictate a maximum safe dose for each drug, and generally have numerous safeguards to prevent the prescription and dispensing of quantities exceeding the highest dosage which has been demonstrated to be safe for members of the general patient population.
Maximum Tolerated Dose Service:
With a decade of experience in drug safety evaluation, Creative Animodel performs pre-clinical toxicology studies in vivo to determine appropriate dosage, frequency and route of administration. Our scientists have an extensive experience to help clients determine maximum tolerable dose of their novel compounds for single and repetitive dosing. Our specifically tailored, individual study designs enable our clients to quickly meet their product development goals. Maximum tolerated dose service includes:
• Maximum tolerated dose (MTD): single or repetitive dosing.
• Multiple animal species including non-human primates, rats, mouse, rabbits, dogs, pigs, etc.
• Diverse routes including intravenous, subcutaneous, intraperitoneal and topical administration.
• 7-day or 28-day clinical observation: clinical signs (including body weight, food consumption and any other abnormal signs), morbidity and mortality.
• Ancillary services: clinical chemistry, urinalysis, hematology, blood gases, histopathology and macroscopic and microscopic necropsy.
Creative Animodel offers maximum tolerated dose (MTD) service for your drug safety evaluation. Our scientists, including toxicologists, pathologists, veterinary surgeons and regulatory specialists, have designed and performed numerous drug safety evaluation. With our skilled staffs, Creative Animodel can conduct standard as well as customized toxicology studies to meet clients’ need and regulatory requirements.