title: Comparative requirements for exploratory clinical trials -- eIND, eCTA and microdosing.
authors.affiliation: Novartis Institutes for BioMedical Research, Cambridge, MA 02139, USA. patrick.mueller@novartis.com
authors.forename: Patrick Y
authors.initials: PY
authors.lastname: Muller
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D001709:Biotechnology / Q000379:methods; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods* / Q000592:standards; D017321:Clinical Trials, Phase I as Topic / Q000331:legislation & jurisprudence / Q000379:methods* / Q000592:standards; D004305:Dose-Response Relationship, Drug; D015507:Drugs, Investigational / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D017408:Guidelines as Topic; D006801:Humans; D007391:International Cooperation; D008954:Models, Biological
chemical_list: D000911:Antibodies, Monoclonal; D015507:Drugs, Investigational