Problem+Set+1

Here is the ProblemSet #1 file. The on-line due date is 06-25-2010. Please download it, answer the questions assigned to your LG (LG-WX, LG from Worcester; LG-MX, LG from Manchester), and upload your answer file back accordingly (below). If you have any problems to upload your file back, please send your file directly to me at jonathan.sheng@mcphs.edu and l will do it for you. Each question will be answered by two LGs independently.

Question A.1: Calculate the pKa value of acetic acid (Ka=1.75 × 10-5) LG-M1: pKa = -log Ka pKa = -log 1.75 × 10-5 pKa = 4.76

LGW1: pKa = -log Ka = -log(1.75x10^-5) pKa = 4.76

Question A.2 LGM2: pKa = -log Ka Ka = 10^-pKa Ka = 10^-9.5 Ka = 3.16x10^-10

LGW2:

Question A.3. LGM3:

Weak acid

LGW3: Weak acid

Question B.1. LGM4: Medicinal chemist role in drug development is multifaceted. They look at the chemical structures of possible candidate substances and determine their biological implications. They also look at different ways they could manipulate chemical structures to get a more effective product or a safer product.

LGW4:

=
Medicinal chemists are involved with the determining the proper chemical structure of a substance to affect a disease state. They alter the properties of the structure and see how that can impact the functional capacity of the drug on whatever the target disease state may be.======

Question B. 2. Explain when and why pharmaceutical companies need to submit IND and NDA. LGM5: After gathering significant evidence of reasonable safety and efficacy in live organisms from pre-clinical trials, an INDA can be filed with the FDA. If approved, the company can commence clinical trials. The NDA is done after Phase III studies to get market approval. It helps the FDA to determine if the new drug meets the criteria to be safe and effective.

LGW5:

The INDA needs to be submitted to get the approval from the FDA to start with clinical trials after preclinical animal investigations. The NDA needs to be submitted after phase III clinical trials before proceeding to post marketing surveillance in phase IV. It is at this point where the FDA evaluates both the safety and efficacy of the new drug.

Question B.3. LGM6:

LGW6: Question B3: Does the labeling of a drug preparation need to be approved by FDA?

Yes. The proposed labeling for a new drug product is included in the NDA. The US FDA reviews all product packaging and labeling for content and clarity, including all statements on the product's package label, package insert, media advertisement and professional literature as these all refer to the labeling of a drug preparation (ref. Foye's pg. 332-333).