Package Inserts

Clinical Pharmacology and PK Sections of the Package Insert

Nearly 25% of the package insert is based on clinical pharmacology, pharmacokinetics, pharmacodynamics and population PK.

Nuventra looks at the impact of clinical pharmacology, PK/PD, and population PK studies on the package insert. We are adept at maximizing the potential of a compound in drug development to gain the most favorable and accurate package insert possible.

Sections of the package insert that emerge from clinical pharmacology, pharmacokinetics, pharmacodynamics and population PK investigations during development:

package insert_reduced

  • DOSAGE AND ADMINISTRATION
    • Dosage in Patients With Renal Impairment
    • Dosage in Patients With Hepatic Impairmen
    • Dosage in Patients Taking XX drug

 

  • CONTRAINDICATIONS

 

  • DRUG INTERACTIONS
    • Strong Inhibitors of Cytochrome P450 3A4:
    • Grapefruit Juice
    • Cyclosporine
    • Rifampin or other Inducers of Cytochrome P450 3A4
    • Digoxin
    • Oral Contraceptives
    • Warfarin

 

  • USE IN SPECIFIC POPULATIONS
    • Pediatric Use
    • Geriatric Use
    • Hepatic Impairment
    • Renal Impairment

 

  • CLINICAL PHARMACOLOGY
    • Mechanism of Action
    • Pharmacodynamics
    • Pharmacokinetics

 

Contact us to start developing a strategy for your package insert.