Clinical Pharmacology Strategy

Mind the Gap: Best Practices in Clinical Pharmacology Gap Analysis

Julie Bullock

Do you get anxious about taking tests? Many people do because they want to show their best efforts. Submitting your New Drug Application (NDA) to the FDA can be thought of as the ultimate test of a drug program. Are you confident that you’ll have robust answers to the 40 different questions that the agency […]

Read More
Topics: Clinical Pharmacology Strategy

PBPK Modeling of Supersaturating Drug Product Behavior

David Turner

The problem of supersaturating drug products might loosely be summed up as: “If you’re not part of the solution, you’re part of the precipitate!” Indeed, more than 60% of new drug candidates are poorly soluble1 which can severely limit their bioavailability. To ameliorate this issue, a common approach is formulating to create supersaturated solutions of […]

Read More
Topics: PBPK Modeling & Simulation

Using Pharmacokinetics to Assure Chemical Food Safety

Ronette Gehring

As a veterinarian, I’m responsible for the health and welfare of my animal patients. Sometimes, drugs are used to treat animals that are being raised for food (e.g., meat and milk). Therefore, tissue residues are a unique concern in veterinary medicine because indirect exposure to drugs and their metabolites through eating meat or milk could […]

Read More
Topics: PK/PD Modeling & Simulation

Navigating the Path for Pharmacokinetic CDISC Data Preparation

Maria Saluta

Data heterogeneity is a regulatory reviewer’s nightmare. Some sponsors talk about patient “gender” whereas others list the patient’s “sex.” What about date formats? Do you use the American-style month-day-year format or the European-style day-month-year? Inconsistent data presentation makes both collaborating on drug development projects and reviewing regulatory submissions more difficult. To address this challenge, the […]

Read More
Topics: PK/PD Modeling & Simulation