Precision Pharmacokinetics for Drug Development.
Pharmacokinetic (PK) data drives key decisions for the development process. By understanding the statistical aspects of a drug’s safety profile, dose(s), dosing frequency the data can optimize the probability of the molecule (agent) to meet the regulatory and statistical criteria for the associated PK/PD endpoints.
Inference’s central objective is to improve the therapeutic outcome with a team of specialists that can analyze all aspects related to PK and Pharmacodynamic (PD) data, and prepare the material required for clinical development purposes.
Our U.S.-based PK statisticians can provide support through flexible FSP or project-based models.
Services Include
We can provide both strategic and tactical suggestions on the PK section of the protocol. The collection of PK data, for plasma or urine or both, not only must be such that the trial objectives can be addressed, but also they need to be looked at with a view of the eventual regulatory submission where additional questions about the drug’s absorption, distribution, metabolism and excretion are well documented.
We have resources with deep experience in PK analysis. Our pharmacokineticist uses WinNonlin to derive the pharmacokinetic parameters according to the methodology specified in the Pharmacokinetics plan or Statistical Analysis Plan (SAP).
Often dosing and go/no-go decisions depend on a favorable relationship between clinical outcomes and a compound’s PK profile. We have extensive experience in modeling this relationship – with biomarker, efficacy and safety data.
We also have experience in performing non-linear modeling for Population PK analysis. Our software of choice is Phoenix NLME.
PARTNER WITH US
When you work with Inference, you gain a trusted partner with the experience, tools, and dedication to support your clinical development goals. Let us simplify the complexities of early-stage drug development to learn key characteristics of the drug so you can focus on late-stage planning to deliver impactful therapeutic solutions. Connect with the Inference team to discuss further.
Kalyan Ghosh, PhD
Chief Executive Officer 
Lisa Hickey, MA
Sr. Director, Biostatistics 
Virginia Bellamy, BA
Sr. Director, Data Management 
Roman Torgovitsky, PhD
Consulting Epidemiologist 
Natasa Rajicic, ScD
Biostatistics/Adaptive Design Strategy 
Anindita Bhattacharjee, MS
Sr. Director, Biometrics 
Anuja Mitra, B. Arch
QA and Contracts 
Ankur Mukherjee, PhD
Associate Director - Statistics 
Tanusree Bhattacharyya, MA
US Operations 