2-3 pages due by 24 hrs

Instructions:

The purpose of this homework is to familiarize the student with FDA’s “Guidance for Industry” documents and ICH Guidelines. Your task is to retrieve the requested documents and answer the questions related to them. We do not expect you to read the documents in detail. Generally, a quick look at the introduction and the general organization of the Guidance or Guideline is sufficient to identify the requested information. The answers are very short and, in many cases, can be copied from the original document and pasted into this Word file.

Problem A:

Please retrieve the draft FDA’s Guidance for Industry on “Clinical Lactation Studies: Considerations for Study Design”

Question 1:

What should a nursing woman volunteer given an investigational drug do with her milk during the duration of the study?

Answer 1:

Question 2:

What are the three types of study designs for clinical lactation studies?

Answer 2:

1.

Problem B:

Please retrieve FDA’s Guidance for Industry “Irritable Bowel Syndrome — Clinical Evaluation of Drugs for Treatment”. This is an example of a Guidance that significantly eliminates uncertainty in the selection of entry criteria and end points when designing trials for a difficult indication.

Question 3:

What are FDA’s criteria recommendations for entering a patient in a clinical trial for IBS-C?

Answer 3:

1.

Question 4:

How does FDA define a Weekly Responder for “Abdominal pain in IBS-C”?

Answer 4:

Problem C:

Please retrieve ICH Guideline Q3A(R2) “Impurities in New Drug Substances”

Question 5:

How is an “Identified Impurity” defined?

Answer 5:

Question 6

What is the meaning of “Qualification” of an impurity?

Answer 6:

Question 7:

You created a new Biotech, Hopeful Pharmaceuticals, and are developing your first drug. The expected human dose is 1.5 grams per day. The Contract Manufacturing Organization (CMO) you contracted just delivered the first large batch of your new drug substance. Among many others, it contains impurity # 13 at the 0.09 % level. Do you need to identify it? Do you need to qualify it? (Hint, use Attachment 1, Thresholds; do not forget to specify the units of the values!).

Answer 7:

Problem D:

Please retrieve ICH Guideline Q1A(R2) “Stability Testing of New Drug Substances and Products”

Question 8:

What is the definition of “Drug substance”?

Answer 8:

Question 9:

What is the definition of “Drug product”?

Question 10:

What is the definition of “Container closure system”?

Answer 10:

Question 11:

In what container closure system should the stability testing of a drug product be performed?

Answer 11:

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