in vivo & in vitro drug investigational involves to which laboratory test
Answers
A sponsor who wishes to conduct a clinical trial that involves an investigational new drug must submit an
Investigational New Drug application (IND) to the FDA. In IND studies, the IND holder is considered to be the
sponsor.
Information that must be provided in an IND
Information that must be provided in an IND includes the following:
The identity and contact information of the sponsor and the phase (or phases) of the trial.
A commitment that an IRB will be responsible for initial and continuing review of the trial.
The name of the drug, a list of its active ingredients, and its dosage and route of administration.
The objectives and planned duration of the proposed clinical trial(s).
A brief description of the plan for investigating the drug, including:
The reasoning behind the drug or the study,
The indication(s) to be studied,
The kinds of clinical trials to be conducted in the first year after the IND submission,
The estimated number of patients who will be given the drug in the clinical trial(s), and
Any serious risks that are anticipated on the basis of animal studies or previous human studies of
this drug or related drugs.
For most trials, a copy of the investigator's brochure.
A protocol for each planned study. (See related material summarized from The Research Protocol
module.)
The identities and qualifications of all investigators. (As demonstrated in a Curriculum Vitae and Form
FDA 1572. Click here for instructions on completing Form FDA 1572.)
The criteria for patient selection and exclusion and an estimate of the number of patients to be studied.
A summary of previous experience with the drug in both animal and human studies, including (if
relevant):
Previous INDs,
Experience with the drug in other countries,
Known safety issues, chemistry and manufacturing information, and
Dependence and abuse potential.
When an IND Goes Into Effect
An IND is considered safe to proceed 30 calendar days after the FDA receives it unless:
The FDA notifies the sponsor that the investigation described in the IND is subject to a clinical hold, or
The sponsor receives written permission from the FDA to begin the study before 30 days have elapsed.
At the sponsor's request, the FDA will provide advice on specific matters relating to an IND. Meetings
between a sponsor and the FDA are frequently useful, and the FDA encourages such meetings to the extent
that FDA resources permit.
IND Exemptions for Studies of Lawfully Marketed Drugs
Studies of lawfully marketed drugs are exempt from the IND regulations if they meet all five of the criteria
listed in 21 CFR 312.2(b)(1). The first four of these criteria are straightforward and need no special comment.
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