
π Pharma & Life Sciences Β· Gantt
The long road from discovery to market for a new drug: research, preclinical, three clinical phases, approval and launch.
Drawing diagramβ¦
Gantt chart of a typical new drug programme: discovery and lead optimisation, preclinical studies, IND filing, Phase 1, Phase 2, Phase 3, manufacturing scale-up in parallel, NDA/marketing authorisation submission and review, and launch.
gantt title New Drug Development Timeline dateFormat YYYY-MM-DD section Research Discovery and lead optimisation :a1, 2026-01-01, 540d Preclinical studies :a2, after a1, 365d IND filing :milestone, a3, after a2, 0d section Clinical Phase 1 safety :b1, after a2, 365d Phase 2 efficacy :b2, after b1, 540d Phase 3 pivotal :b3, after b2, 900d section Manufacturing Process scale-up :c1, after b2, 720d section Regulatory Submission and review :d1, after b3, 365d Launch :milestone, d2, after d1, 0d
The states of a laboratory sample in a LIMS, from collection to reporting and disposal, with rejection and re-testing.
How a suspected side effect reported by a doctor or patient is captured, assessed and reported to the regulator on time (pharmacovigilance).
The systems that run a clinical trial: trial management, electronic data capture, randomisation, drug supply and safety reporting.
How medicine packs are serialised and traced from factory to pharmacy to stop counterfeits: unique codes, aggregation and verification.
How a pharmaceutical company prepares and files a marketing application (dossier) with regulators and handles their queries.
A schema for electronic batch records in pharmaceutical manufacturing: products, master recipes, batches, steps, materials used and deviations.