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The assumption baked into every pharmacovigilance system — and why it fails CAR-T patients
Advanced Oncology Safety

The assumption baked into every pharmacovigilance system — and why it fails CAR-T patients

Conventional pharmacovigilance was built for drugs that reveal their toxicity slowly. CAR-T does the opposite — and the mismatch is a patient-safety problem, not a paperwork problem.

Dr. Ashok Srivastava2026-06-09
CAR-T toxicity 101: what every sponsor safety team needs before the first patient is dosed
Advanced Oncology Safety

CAR-T toxicity 101: what every sponsor safety team needs before the first patient is dosed

A working orientation to CRS and ICANS for safety and clinical development teams — what to define before enrollment, not after the first event.

Dr. Ashok Srivastava2026-06-04
ADCs are not chemotherapy: a clinical briefing on organ-specific toxicity
Advanced Oncology Safety

ADCs are not chemotherapy: a clinical briefing on organ-specific toxicity

Antibody-drug conjugates carry a targeted-toxicity profile that conventional chemotherapy monitoring is poorly shaped to catch. Treating them alike is a clinical safety error.

Dr. Ashok Srivastava2026-05-21
RLT safety monitoring: marrow reserve, renal function, and the dosimetry gap
Advanced Oncology Safety

RLT safety monitoring: marrow reserve, renal function, and the dosimetry gap

Radioligand therapy carries a safety problem most pharmacovigilance teams are not trained to see — one that lives in cumulative dose, marrow reserve, and renal clearance.

Dr. Ashok Srivastava2026-05-14
The Acute Multi-Organ Instability Phase (AMOIP): a clinical reference
Advanced Oncology Safety

The Acute Multi-Organ Instability Phase (AMOIP): a clinical reference

There is a clinical window in advanced-therapy toxicity that conventional pharmacovigilance was not designed to see. We call it AMOIP — and naming it changes how you govern it.

Dr. Ashok Srivastava2026-05-07
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