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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
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

Study design. The study included single and multiple ascending... |  Download Scientific Diagram
Study design. The study included single and multiple ascending... | Download Scientific Diagram

On Biostatistics and Clinical Trials: SAD and MAD: Single Ascending Dose  and Multiple Ascending Dose first-in-human studies
On Biostatistics and Clinical Trials: SAD and MAD: Single Ascending Dose and Multiple Ascending Dose first-in-human 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
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

Pharmacokinetics of ASP4345 from Single Ascending-Dose and Multiple  Ascending-Dose Phase I Studies | SpringerLink
Pharmacokinetics of ASP4345 from Single Ascending-Dose and Multiple Ascending-Dose Phase I Studies | SpringerLink

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 ...
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 ...

Pharmacokinetics of ASP4345 from Single Ascending-Dose and Multiple  Ascending-Dose Phase I Studies | SpringerLink
Pharmacokinetics of ASP4345 from Single Ascending-Dose and Multiple Ascending-Dose Phase I Studies | SpringerLink

Statistical considerations in exploratory studies
Statistical considerations in exploratory studies

JCI - Monoclonal antibody targeting BDCA2 ameliorates skin lesions in  systemic lupus erythematosus
JCI - Monoclonal antibody targeting BDCA2 ameliorates skin lesions in systemic lupus erythematosus

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
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

Planning Your (First) First-in Human Trial? Considerations for Success -  Xtalks
Planning Your (First) First-in Human Trial? Considerations for Success - Xtalks

Types of Study in Early Clinical Development - EUPATI Toolbox
Types of Study in Early Clinical Development - EUPATI Toolbox

Phase I Trial of Anti–Vascular Endothelial Growth Factor/Anti-angiopoietin  2 Bispecific Antibody RG7716 for Neovascular Age-Related Macular  Degeneration - ScienceDirect
Phase I Trial of Anti–Vascular Endothelial Growth Factor/Anti-angiopoietin 2 Bispecific Antibody RG7716 for Neovascular Age-Related Macular Degeneration - ScienceDirect

Single and multiple ascending dose GS-9256 and GS-9451 clinical trial... |  Download Scientific Diagram
Single and multiple ascending dose GS-9256 and GS-9451 clinical trial... | Download Scientific Diagram

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
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

Phase I: Overview
Phase I: Overview

On Biostatistics and Clinical Trials: SAD and MAD: Single Ascending Dose  and Multiple Ascending Dose first-in-human studies
On Biostatistics and Clinical Trials: SAD and MAD: Single Ascending Dose and Multiple Ascending Dose first-in-human studies

Results from a phase 1, randomized, double-blind, multiple ascending dose  study characterizing the pharmacokinetics and demonstrating the safety and  selectivity of the aldosterone synthase inhibitor baxdrostat in healthy  volunteers | Hypertension Research
Results from a phase 1, randomized, double-blind, multiple ascending dose study characterizing the pharmacokinetics and demonstrating the safety and selectivity of the aldosterone synthase inhibitor baxdrostat in healthy volunteers | Hypertension Research

example single ascending dose study design incorporating a CsF-sampling...  | Download Scientific Diagram
example single ascending dose study design incorporating a CsF-sampling... | Download Scientific Diagram

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
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

Multiple-Ascending-Dose Phase 1 Clinical Study of the Safety, Tolerability,  and Pharmacokinetics of CRS3123, a Narrow-Spectrum Agent with Minimal  Disruption of Normal Gut Microbiota | Antimicrobial Agents and Chemotherapy
Multiple-Ascending-Dose Phase 1 Clinical Study of the Safety, Tolerability, and Pharmacokinetics of CRS3123, a Narrow-Spectrum Agent with Minimal Disruption of Normal Gut Microbiota | Antimicrobial Agents and Chemotherapy

Single and Multiple Ascending-dose Studies of Oral Delafloxacin: Effects of  Food, Sex, and Age - ScienceDirect
Single and Multiple Ascending-dose Studies of Oral Delafloxacin: Effects of Food, Sex, and Age - ScienceDirect

A Flow-chart of the single-ascending-dose (SAD) and... | Download  Scientific Diagram
A Flow-chart of the single-ascending-dose (SAD) and... | Download Scientific Diagram

ONCE-DAILY REGIMENS OF THE HCV NS3/4A-PROTEASE INHIBITOR TMC435350 ARE  PREDICTED TO PROVIDE THERAPEUTIC EXPOSURE IN PLASMA AND LIVER
ONCE-DAILY REGIMENS OF THE HCV NS3/4A-PROTEASE INHIBITOR TMC435350 ARE PREDICTED TO PROVIDE THERAPEUTIC EXPOSURE IN PLASMA AND LIVER