Study Set Content:
Addition of formulation components to create a successful pharmaceutical product
Stability
Particle size
Physical Form
• Absorption
Stability
Dosage form, Dosage strength, Route of administration
Initial Product Formulation and Clinical Trial Materials
Initial formulations
Initial Product Formulation and Clinical Trial Materials
Clinical supplies
Initial Product Formulation and Clinical Trial Materials
Hydrolysis: moisture in packaging
Stability
Heat and Humidity
Stability
Filed when adequate safety and usefulness as a new drug has been demonstrated through preclinical studies
Investigational New Drug Application
Contents:
Code of Federal Regulations • Form FDA-1571
Protects the safety and rights of the human subjects
FDA Review of an IND Application
Ensures that the study allows the evaluation of the drug’s safety and effectiveness
FDA Review of an IND Application
Controlled clinical studies for effectiveness in patients with the condition
• Phase II
Several hundred to several thousand patients in controlled and uncontrolled trials
Phase III
Determine human pharmacology of the drug, structure–activity relationships, side effects with increasing doses, possible early evidence of effectiveness
• Phase I
Clinical Study Controls and Designs
Active drug • Placebo control • Study designs
Usual dose • Dosage regimen • Initial/Priming/Loading dose • Maintenance dose • Prophylactic dose • Therapeutic dose • Minimum Effective Concentration • Minimum Toxic Concentration • Median Effective Dose (ED50) • Median Toxic Dose (TD50)
Drug Dosage and Terminology
Age • Pharmacogenetics • Body weight • Body surface area • Sex • Pathologic state • Tolerance • Concomitant drug therapy • Time and conditions of administration • Dosage form and route of administration
Drug Dosage and Terminology
Permits the use of an investigational drug in patients not enrolled in a clinical study.
Treatment IND
Patients have serious or immediately life-threatening disease.
Treatment IND
