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When to Use PopPK/PD, Exposure Response, PBPK, and QSP, and When Not To 1. Introduction: Why Quantitative Pharmacology Matters Model informed development has shifted from optional exploratory analysis to a central part of decision making. Most high value decisions such as target viability, mechanism plausibility, first in human (FIH) dose selection, Phase 2 dose justification, […]

Introduction Oncology drug development has traditionally shunned healthy volunteer (HV) participation due to the high toxicity of classic chemotherapies [1]. Cytotoxic agents non-selectively kill rapidly dividing cells, causing severe side effects that would be unethical in individuals without cancer. However, the therapeutic landscape is changing. Over the past two decades, targeted therapies—drugs aimed at specific

Even if you never build a PBPK model in-house, an early decision framework—knowing when PBPK can replace, complement, or simply de-risk clinical studies—cuts duplicated work and answers “what-if” regulatory questions before they become clock-stopping RFIs. Why deciding early—not necessarily modeling early—saves studies, budget, and review stress Small molecule therapies—and, occasionally, intravenous antibody–drug conjugates (ADCs) carrying

Emerging biotech companies—and small to midsize pharma firms—face extraordinary constraints. Timelines are compressed, funding is finite, and regulatory expectations continue to evolve. These pressures make it essential to have a strategic development plan that integrates scientific rigor, operational efficiency, and regulatory foresight from the earliest stages. Biotech innovation is advancing at remarkable speed—but development timelines,