Bhaswat Chakraborty

bioequivalence ct clinicaltrials clinical trials replicate design clinical biosimilars pk pharmacokinetics plasma proteins drugs clinical pharmacovigilance drug discovery quality drug-products confidence intervals acceptance limits data cancer phase ii trials biosimilar non-clinical regulatory development pharmacists pre-clinical. ethics nanotechnology toxic signals bayesian go no go phase ii cancer ct drug delivery system individual polpulation average science career risk management fda india glp gcp fda patent exclusivity integrity technical writing grammar style clinical trial medical devices pivotal primary objective gdufa ii complex generics crossover parallel fed studies mrdfs non=linear ivrt ivpt orally inhaled mdi respiratory pbpk two period crossover outliers root cause analysis pharmacy clinical research bioethics data integrity risk based approaches plagiarism originality anti-plagiarism softwares root cause five ways to stop plagiarism mpharm bpharm adaptation intra-personal inter-personal newton nda bla us fda clinical pharmacology safety efficacy corrective and preventive action