CRO / Research Services Provider · +2 more types
Products: ClinQuick
“Celerion’s proven expertise in BA/BE studies combines regulatory compliance with operational excellence to deliver reliable, high-quality data for your generic drug development…”Source: celerion.com
Also offers: First-in-Human (Phase I) Clinical Pharmacology Support, Clinical Trial Bioanalytical & Biomarker Testing, +1 more
Software / Technology Platform · +4 more types
Products: GastroPlus, MonolixSuite +9 more
“Virtually simulate bioequivalence trials to compare predicted PK profiles from reference and test products, or justify the use of new dosage strengths”Source: simulations-plus.com
Also offers: Model-Informed Drug Development (MIDD), PBPK Modeling, +3 more
CRO / Research Services Provider · +3 more types
Products: Acceleration Platform
“Altasciences has been at the forefront of bioavailability (BA) and bioequivalence (BE) testing since our founding.”Source: altasciences.com
Also offers: Toxicology Studies, First-in-Human (Phase I) Clinical Pharmacology Support, +2 more
CRO / Research Services Provider · +1 more type
“…Bioavailability and Bioequivalence Studies We design and execute BA/BE studies in compliance with COFEPRIS, FDA, and EMA requirements — a critical step for generic drug approvals…”Source: althian.com
Also offers: Full-Service Clinical Trial Execution (CRO Services), Marketing Authorization & Lifecycle Submission Support, +3 more
Service Provider · +2 more types
Products: D.AI.M.I.
“First-in-human dose justification and Phase 2/3 trial simulations”Source: plglifesciences.com
Also offers: Regulatory Development Strategy & Agency Interactions, End-to-End Pharmacovigilance Outsourcing, +6 more
CRO / Research Services Provider · +5 more types
“Bioavailability/Bioequivalence”Source: frontagelab.com
Also offers: Bioanalysis & Biomarker Assay Services, Integrated CDMO/CMO Services, +3 more
CRO / Research Services Provider · +2 more types
Products: InStat, CoAuthor
“Selection of dose escalation and dose optimization design”Source: veristat.com
Also offers: Biostatistics & Statistical Programming, Full-Service Clinical Trial Execution (CRO Services), +3 more
CRO / Research Services Provider · +5 more types
Products: Teklad, Target Sufficiency +1 more
“The team supports PK/ PD sample analysis, drug–drug interaction studies, concomitant drug analysis, and bioequivalence programs.”Source: inotiv.com
Also offers: Toxicology Studies, In Vivo Pharmacology & Efficacy Models, +3 more
CRO / Research Services Provider · +7 more types
Products: IQVIA Vigilance Platform, SmartSolve +4 more
“When you need additional support in defining the optimal dose for latter phase trials, we can help through greatly improving the probability of success.”Source: iqvia.com
Also offers: Full-Service Clinical Trial Execution (CRO Services), Real-World Data Platform, +6 more