PBPK Modeling & Simulation

Mechanistic Modeling of Antibody Drug Conjugate Pharmacokinetics

Linzhong Li

Antibody Drug Conjugates (ADCs) are constructed by attaching a small molecule drug to an antibody via a linker. The antibody selectively targets tumor cells and releases the cytotoxic drug within the cells to kill cancerous cells while sparing healthy tissue. Although some ADCs have been approved, many unanswered questions remain, such as drug-drug interactions (DDIs) and […]

Read More
Topics: PBPK Modeling & Simulation

Regulatory Writing Experts: Superman or Clark Kent?

Tatyana Wanderer

The day starts out slowly. The clinical lead settles into her comfy chair, pushes up her glasses just a bit and gazes at the shimmering computer screen, as the spring breeze sways the branches on the other side of the window. Then, one email (bing)…two emails (bing, bing)… ten, twenty! The beeps roar like a […]

Read More
Topics: Regulatory & Medical Writing