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IND Decision Tool
IND Exemption Form
Introduction
Highlights of FDA History
FDA vs. OHRP
What FDA Regulates
FDA Authorities
FDA Centers
Clarifying the "new" in IND
Assessing Preclinical Data
Properties of the Study Drug
How the Data is Used
IND Submission
IND Holder Reponsibilities

Properties of the study drug

Another factor to consider when determining the need for an IND is how the study drug will be physically modified for the purposes of the study. This may actually place the subject in a situation of unanticipated risks. Consider if the following issues:

Changing the Form of the Drug
Some drugs have an encapsulation or coating that can be a protectant or can have special properties that determine the location and rate at which the drug is absorbed.

Example: Coumadin® is very unstable in high humidity, which is why the pills are coated. Crushing of these caplets can change them chemically and result in unanticipated safety risks and a lack of efficacy.

Example: Niaspan® pills are specially formulated to control the rate of absorption of the drug to reduce side effects and maintain consistent drug delivery over a 24-hour period.  Crushing the Niaspan® pill (such as one might do to put a drug in a gelatin capsule for study blinding) would cause the drug to be absorbed much more rapidly. This would lead to significant side effects, a markedly shortened duration of drug delivery, and wide variations in peak drug concentration.

Manufacturing Issues
Good Manufacturing Processes (GMP) dictate that proper controls are in place to ensure the product is safe, the stability is known, and that the product’s storage or delivery system is effective. These regulations are just as important as regulations on clinical drug development in the protection of human patients/subjects.

Example: A cytotoxin used in a psoriasis study would not only have potentially unacceptable toxicities in that setting but it might also expose the research team, who is not familiar with the safe handling of cytotoxins, to be at increased risk.

Example: The packaging of some drugs is very important to preserve its chemical composition. Some drugs are in blister packs, for example, because they decompose when they come in contact with air. Other drugs must be maintained in a dark brown glass bottle, as they are photosensitive.