Obeticholic Acid—From PK Model to Drug Label
Watch this webinar with Jeffrey Edwards to learn how he used physiologic pharmacokinetic modeling to…
CertaraJune 1, 2017
Rare Disease and Orphan Drug Development
There are 7,000 rare diseases impacting 350 million patients worldwide, yet only 300 of these…
CertaraAugust 3, 2016
Population Pharmacokinetic and Pharmacodynamic Analyses from a 4-Month Intra-dose Escalation and Its Subsequent 12-month Dose Titration Studies for a Human Monoclonal Anti-FGF23 Antibody (KRN23) in Adults with X-linked Hypophosphatemia
X-linked hypophosphatemia (XLH) is an inherited metabolic bone disease with abnormally elevated serum FGF23 resulting…
CertaraApril 1, 2016
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…
CertaraFebruary 15, 2015
Ammonia Control in Children with Urea Cycle Disorders (UCDs); Phase 2 Comparison of Sodium Phenylbutyrate and Glycerol Phenylbutyrate
Twenty four hour ammonia profiles and correlates of drug effect were examined in a phase…
CertaraAugust 1, 2011
Pharmacokinetics of Clofarabine in Patients with High-risk Inherited Metabolic Disorders Undergoing Brain-sparing Hematopoietic Cell Transplantation
Clofarabine, a newer purine analog with reduced central nervous system toxicity, may prove advantageous in…
CertaraMay 1, 2011
Pharmacology and Safety of Glycerol Phenylbutyrate in Healthy Adults and Adults with Cirrhosis
Phenylbutyric acid (PBA), which is approved for treatment of urea cycle disorders (UCDs) as sodium…
CertaraJune 1, 2010
