Pediatric Drug Dosing: Tackling Big Problems for Little Patients
儿科药物开发的挑战与复杂性已广为人知。Pharmacometric modeling and simulation (M&S)…
Certara2015 年 4 月 23 日
Effect of Age and Sex on the Pharmacokinetics and Safety of Avibactam in Healthy Volunteers
Avibactam is a novel non-β-lactam β-lactamase inhibitor currently being assessed in combination with ceftazidime, ceftaroline…
Certara2015 年 4 月 1 日
Modeling and Simulation to Support Phase 2 Dose Selection for RG7652, a Fully Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9
RG7652 is a fully humanized monoclonal antibody targeting human PCSK9, a regulator of serum low…
Certara2015 年 3 月 31 日
Safety and Pharmacokinetics of Single and Multiple Ascending Doses of Avibactam Alone and in Combination with Ceftazidime in Healthy Male Volunteers: Results of Two Randomized, Placebo-controlled Studies
Avibactam is a novel non-β-lactam β-lactamase inhibitor effective against Ambler class A, C and some…
Certara2015 年 3 月 27 日
Chemotherapy of Second Stage Human African Trypanosomiasis: Comparison Between the Parenteral Diamidine DB829 and Its Oral Prodrug DB868 in Vervet Monkeys
Human African trypanosomiasis (HAT, sleeping sickness) ranks among the most neglected tropical diseases based on…
Certara2015 年 2 月 15 日
Population Pharmacokinetics of Ceftolozane/Tazobactam in Healthy Volunteers, Subjects with Varying Degrees of Renal Function and Patients with Bacterial Infections
Ceftolozane/tazobactam is a novel antipseudomonal cephalosporin and a β-lactamase inhibitor in clinical development for treatment…
Certara2015 年 2 月 1 日
Common Misconceptions About Computer System Validation
Drug development professionals frequently use computer systems to help them understand the pharmacokinetics (PK) and…
Certara2015 年 1 月 28 日
Using Modeling and Simulation to Quantify the PK of an Anti-HIV Drug for Babies
As a scientist at Certara and proud Dad to my three kids, pediatric drug development…
Certara2015 年 1 月 15 日
Prediction of the Pharmacokinetics, Pharmacodynamics, and Efficacy of a Monoclonal Antibody, Using a Physiologically-based Pharmacokinetic FcRn Model
Although advantages of physiologically based pharmacokinetic models (PBPK) are now well established, PBPK models that are linked to pharmacodynamic…
Certara2015 年 1 月 5 日
