DMPK Study for IND Filing
Creative Animodel focuses on DMPK study for IND filing to provide our clients high-quality safety assessments services. Our services include animal pharmacology and toxicology studies, and also provide chemistry information. While timing is always an important factor in filing an IND, our efforts to prepare a well-thought and comprehensive DMPK study plan will, in most cases, save your time and resources.
What Is IND Filing?
The filing of an IND is the first step in the drug development process. The IND contains nonclinical pharmacology in animal disease models, toxicology in two animal species of duration that does not exceed the duration of the proposed first clinical trials, preliminary ADME data, an Investigator‘s Brochure, protocol synopsis of the proposed clinical trial, and CMC information. Prior to the IND filing it is usual to have a pre-IND meeting with the reviewing division, where what the IND will contain is presented and FDA input is solicited as to its “acceptance”. In general, the duration of the toxicology studies, the dose ranges used, the NOAELs obtained, and the safety margins that are estimated determine the final clinical protocol. A typical toxicology package to support filing an IND contains data from the following studies: acute toxicity profile in rodent and one or more nonrodent species, a dose ranging finding study in rodent and one or more nonrodent species, and repeat dose toxicity study with recovery in one rodent and one nonrodent species.
DMPK Study for IND Filing at Creative Animodel
|Hit identification||Target identification and validation, physical chemistry assays|
|Lead optimization||In vivo efficacy assays (preclinical proof of concept), in vitro ADME assays, and preliminary PK and toxicology studies|
|Preclinical development||PK/PD modeling, salt form selection, crystal form assessment; safety pharmacology assays|
• Extensive experience in the field of IND filing
• Various study types offered to meet our clients’ requirements
• Short duration and competitive price
Creative Animodel can assist you with IND filing in DMPK study, our excellent in-house specialists with professional drug metabolism and pharmacokinetics knowledge will offer professional support for your drug discovery project and facilitate your drug development process. Please contact us to learn how we can help you with your needs. We look forward to working with you in the near future.