Microdosing and Exploratory IND

Microdosing

Microdosing and Exploratory-IND Studies

Microdosing and Exploratory IND Services

Obtain early human PK
Select the best lead candidate from multiple preclinical candidates
Add value to drug pipeline with early clinical data

Exploratory IND Studies

Exploratory IND studies are intended to provide clinical information for a new drug candidate at a much earlier phase of drug development. These studies help to identify the best candidates for continued development and eliminate those lacking promise. These clinical trials occur very early in Phase 1, involve very limited human exposure, and have no therapeutic intent. Exploratory IND studies are conducted prior to the traditional dose escalation, safety, and tolerance studies and provide important information on pharmacokinetics (PK) and bioavailability of a candidate drug.

In April 2005, the FDA released a draft guidance for Exploratory IND studies that clarifies preclinical and clinical approaches that should be considered when planning exploratory IND studies in humans. As part of FDA’s “Critical Path Initiative”, this process is a new tool available to the industry that enables a faster, more cost-effective path to early clinical development.

Microdosing

A primary application of an Exploratory IND study is Microdosing or Phase 0 Clinical Trials. Microdosing studies permit collection of human pharmacokinetic (PK) and bioavailability data earlier in the drug development process. This human data is combined with preclinical data to select the best candidates to advance to further, more expensive and extensive clinical development. A microdose is defined as less than 1/100^th of the dose calculated to yield a pharmacological effect of a test substance and a maximum dose of <100 micrograms. Since microdosing studies are designed not to induce pharmacological effects, the potential risk to human subjects is very limited. Therefore, these studies can be initiated with less preclinical safety data, help reduce the number of human subjects needed and require fewer resources for selecting promising drugs candidates for further development.

Save Time and Money with Microdosing Studies

Industry estimates for traditional approaches (IND) of obtaining first-in-human data are between $1.5 million to $3.0 million and require upwards of 18 months of time. In most cases, a microdosing study can be conducted for less than $500,000. With adequate supporting data, microdosing studies can be completed in less than six months.

Advantages of Microdosing

Select the best lead compound supported by clinical data
Save time: Advance lead candidates to clinical development in months not years
Save money: Significantly reduced IND submission requirements and costs
Cost-effective approach to adding value to lead candidate or drug pipeline

Single-dose Toxicity Study in Support of Microdosing Studies

Single mammalian species justified by in vitro metabolism data
Single does exposure via intended clinical route
14 day observation with interim sacrifice at day 2
Establish dose inducing minimal toxic effect or a margin of safety of clinical dose (e.g. 100x)
Endpoints include: body weight, clinical signs, chemistry, hematology and histopathology
No genetic toxicology required

AMS Bioanalytical Services in Support of Microdosing Studies

Accelerator Mass Spectrometry (AMS) is an ultrasensitive bioanalytical platform capable of quantifying ¹⁴C-labeled compounds with attomole(10^-18M) sensitivity. The exceptional sensitivity of AMS enables microdosing studies performed at subpharmacologic levels. As the first company to operate a commercial bioanalytical AMS core facility in the U.S., Accium BioSciences offers a range of services dedicated to early phase drug development. Please contact Accium BioSciences to learn more about microdosing, Exploratory IND studies and AMS bioanalytical services in support of microdosing studies.

Please call +1 (206) 281-3915 to learn more information about our AMS bioanalytical services.