Informing Pediatric Drug Development: A Selection from Certara’s Best of Blogs

A selection of short essays by Certara’s pediatric drug development experts. Learn about our technologies and strategies for pediatric drug development to inform dose selection, including PK/PD simulations using sparse data analysis and our Simcyp Pediatric Simulator. Certara’s regulatory writing consultancy, Synchrogenix, also offer regulatory strategy for pediatrics.

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Certara’s Best of Blogs 2015

A selection of short essays from our blog, written to empower our customers with biosimulation and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing.

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Phase I safety, pharmacokinetic and pharmacodynamic trial of BMS-599626 (AC480), an oral pan-HER receptor tyrosine kinase inhibitor, in patients with advanced solid tumors.

We studied the safety, tolerability, and recommended dose of BMS-599626, an orally bioavailable inhibitor of the human epidermal growth factor receptor (HER) family of receptor tyrosine kinases. Patients with advanced solid tumors that expressed epidermal growth factor receptor (EGFR) and/or HER-2 were recruited and enrolled in a phase I, open-label, dose escalation trial of oral […]

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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 2 comparison of sodium phenylbutyrate (NaPBA) and glycerol phenylbutyrate (GPB or HPN-100), an investigational drug being developed for urea cycle disorders (UCDs). Study Design: Protocol HPN-100-005 involved open label fixed-sequence switch-over from the prescribed NaPBA dose to a PBA-equimolar GPB […]

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Population pharmacokinetics of teduglutide following repeated subcutaneous administrations in healthy participants and in patients with short bowel syndrome and Crohn’s disease

Teduglutide is a GLP-2 analog currently evaluated for the treatment of short bowel syndrome, Crohn’s disease, and other gastrointestinal disorders. The population pharmacokinetics (PK) of teduglutide were assessed following daily subcutaneous (SC) administrations of 2.5 to 80 mg doses in a total of 256 patients. A 1-compartment model with a site-specific rate constant of absorption […]

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Pharmacokinetics, Safety, and Tolerability of Teduglutide, a Glucagon-Like Peptide-2 (GLP-2) Analog, Following Multiple Ascending Subcutaneous Administrations in Healthy Subjects

Teduglutide, a glucagon-like peptide-2 (GLP-2) analog, is currently being evaluated for the treatment of short-bowel syndrome, Crohn’s disease, and other gastrointestinal disorders. The pharmacokinetics, safety, and tolerability of teduglutide in healthy subjects (N = 64) were assessed following daily subcutaneous administrations for 8 days in a double-blinded, randomized, placebo-controlled, ascending-dose study. Teduglutide treatments were administered […]

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Pharmacokinetic Analysis of Capsaicin After Topical Administration of a High-Concentration Capsaicin Patch to Patients With Peripheral Neuropathic Pain

Capsaicin, a pungent compound in chili peppers, is a highly selective agonist for the transient receptor potential vanilloid 1 receptor expressed in nociceptive sensory nerves. A high-concentration (640 μg/cm2) capsaicin patch, designated NGX-4010, is in clinical evaluation for the management of peripheral neuropathic pain. To determine systemic capsaicin exposure after single 60- or 90-minute NGX-4010 […]

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Pharmacokinetics of Injectable, Long-acting Nevirapine for HIV Prophylaxis in Breastfeeding Infants.

Mother-to-child transmission (MTCT) of HIV-1 remains a global health problem. The World Health Organization (WHO recommendations advise the administration of a once-daily, oral, prophylactic regimen of the nonnucleoside reverse transcriptase inhibitor nevirapine (NVP) from birth until four to six weeks of age for infants born to HIV-infected mothers in regions without access to safe and […]

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How Biosimulation Technology Could Save Us from the Zombie Apocalypse

Martin Beliveau

Skeptical at the idea of ravenous brain-eating undead? You don’t have to take my word for it. The Centers for Disease Control and Prevention (CDC) Office of Public Health Preparedness and Response recognizes this threat. Their Zombie Preparedness website provides information on getting ready for all kinds of disasters.

Biosimulation technology can help fight the Walking Dead. Zombie plague, like other serious infectious diseases, presents unique challenges to drug development. One challenge is that exposing humans to these pathogens in drug efficacy studies is unethical. Biosimulation methods include ‘top down’ approaches such as PK/PD modeling and simulation and ‘bottom up’ approaches such as PBPK modeling and simulation. These approaches can use animal studies and simulate clinical trials to help prove a drug’s safety and efficacy in untestable clinical scenarios.

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Topics: Drug Safety, Model-based Drug Development, PK/PD Modeling and Simulation

Using Biosimulation to Quantify the PK of an anti-HIV Drug for Babies

Martin Beliveau

As a scientist at Certara and proud Dad to my three kids, pediatric drug development is a topic that is near to my heart. Clearly, children are not just “small adults.” They require special consideration for their distinct physiology during drug development. Likewise, for ethical reasons, it is important to minimize children’s exposure to experimental […]

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Topics: Drug Safety, Model-based Drug Development, PK/PD Modeling and Simulation
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