Clinical Pharmacology

Let us enhance the efficacy of your clinical pharmacology studies by providing guidance specific to your programs, based on decades of combined experience. By utilizing the right tools, knowledge of the regulatory process, and meticulous analysis of your data, we can ensure that you create the best study design and plan for the future. We aim to be a seamless extension of your team.

We perform gap analysis for your Pharmacology, Toxicology, and DMPK studies for both small and large molecules. We then provide mitigation actions for the gaps identified and help you assess your First in Human (FIH)/First in Patient (FIP) dose escalation study. Using expert knowledge in CMC and pharmaceutical sciences, we can help support your formulation development activities. We provide help with drafting the Pre-IND Briefing Document, and if needed will attend regulatory meetings to defend the company's position and answer the agency's questions.

We design all traditional Clinical Pharmacology studies and will take care of CRO placement, conduct, PK analysis, and reporting. Examples of these studies include:

1. BA/BE
2. Drug-Drug interaction
3. Ethnic Bridging
4. Food-Effect
5. Mass-Balance
6. Organ (renal/hepatic) dysfunction
7. QT

Receive support identifying the start dose and with drafting the First in Human (FIH)/First in Patient (FIP) protocol, including the dose-escalation phase (Phase Ia) and dose-expansion phase (Phase Ib). We design the sampling schedules, help with identifying doses for the expansion phase, and will also conduct any necessary quantitative analyses, including NCA, Population PK, and Exposure-Response (ER) analyses of safety and efficacy. We perform all categorical and ER analyses needed to meet FDA Project Optimus requirements, as well as identifying a recommended Phase II dose (RP2D).

Once a recommended Phase II dose (RP2D) is identified, we provide support with drafting the briefing document and defense of your RP2D with regulatory agencies. Guidance for the pivotal protocol and sampling strategy for submission can be provided as well, based on quantitative analysis. Quantitative work includes performing and reporting Population PK, ER analysis of safety and efficacy, and Concentration-QT analysis. Defense of the pivotal trial dose(s) and improvement of labeling language will be in mind during this stage for NDA/BLA submissions. We can help with writing submission documents as well, such as 2.7.1 (SBS) and 2.7.2 (SCP).