Pharmacokinetics of ASP4345 from Single Ascending-Dose and Multiple Ascending-Dose Phase I Studies | SpringerLink
Types of Study in Early Clinical Development - EUPATI Toolbox
A phase I, randomized, observer-blinded, single and multiple ascending-dose study to investigate the safety, pharmacokinetics, and immunogenicity of BITS7201A, a bispecific antibody targeting IL-13 and IL-17, in healthy volunteers | BMC Pulmonary
CLINICAL STUDY PROTOCOL A Phase 1A Single Ascending Dose and Multiple Ascending Dose Double-Blind, Placebo-Controlled, Randomize
A Phase I, Randomized, Single‑Blind, Placebo‑Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Oral TRV250, a G Protein-Selective Delta Receptor Agonist, in Healthy Subjects | SpringerLink
Pharmacokinetics, Safety and Tolerability of the HCV Polymerase Inhibitor ABT-333 Following Multiple Ascending Doses and Effect of Co-Administration of Ketoconazole in Healthy Subjects
Phase I Clinical Trials — Celine Halioua
example single ascending dose study design incorporating a CsF-sampling... | Download Scientific Diagram
A randomized, placebo-controlled, single ascending-dose study to assess the safety, tolerability, pharmacokinetics, and immunogenicity of subcutaneous tralokinumab in Japanese healthy volunteers - ScienceDirect
Study design: (A) single ascending dose; (B) multiple ascending dose. | Download Scientific Diagram
Traditional Process First in Human Single Ascending Dose Multiple Ascending Dose U.S.A. Japan Phase II Phase III NDA in Japan Phase II Phase III NDA in. - ppt download
Innovative Randomized Phase 1 Study and Dosing Regimen Selection to Accelerate and Inform Pivotal COVID-19 Trial of Nirmatrelvir | medRxiv
Two Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Studies To Investigate the Safety, Tolerability, and Pharmacokinetics of an Anti-Influenza A Virus Monoclonal Antibody, MHAA4549A, in Healthy Volunteers | Antimicrobial ...
A First‐in‐Human Phase 1 Randomized Single and Multiple Ascending Dose Study of RPh201 in Healthy Volunteers - Hazan - 2020 - Clinical Pharmacology in Drug Development - Wiley Online Library
Statistical considerations in exploratory studies
A phase I, randomized, observer-blinded, single and multiple ascending-dose study to investigate the safety, pharmacokinetics, and immunogenicity of BITS7201A, a bispecific antibody targeting IL-13 and IL-17, in healthy volunteers | BMC Pulmonary
Schematic of the ECG timepoints and meals in the single-ascending dose... | Download Scientific Diagram
On Biostatistics and Clinical Trials: SAD and MAD: Single Ascending Dose and Multiple Ascending Dose first-in-human studies
Recommendations on integrated safety summaries from Phase 1 studies - ppt download
Clinical trial phases, requirements and regulations
ONCE-DAILY REGIMENS OF THE HCV NS3/4A-PROTEASE INHIBITOR TMC435350 ARE PREDICTED TO PROVIDE THERAPEUTIC EXPOSURE IN PLASMA AND LIVER
Evaluation of single and multiple doses of a novel mGlu2 agonist, a potential antipsychotic therapy, in healthy subjects - McColm - 2017 - British Journal of Clinical Pharmacology - Wiley Online Library
