Absorption (testing) - answer✔✔To see that the drug passes GI track into blood stream
Distribution (testing) - answer✔✔To see that the the drug gets to target tissue
Metabolism (testing) - answer✔✔To see that the drug is not readily metabolized
Excretion (testing) - answer✔✔To see that the drug is not readily secreted
Toxicity (testing) - answer✔✔To see that the drug is not toxic to other cells or tissue
Biologic Pre-clinical Tests - answer✔✔Pharmacology, Drug metabolism and toxicology
experiments
Preformulation Studies - answer✔✔1) Drug solubility
2) Partition coefficient
3) Dissolution rate
4) Physical form
5) Stability
Clinical Phase I - answer✔✔Study's absorption/metabolism, effects on organs and tissue and
side effects on ~20-100 healthy volunteers
IND - answer✔✔Investigational New Drug Application
Clinical Phase II - answer✔✔Studies effectiveness in treatment, short-term side effects and dose
range on a large number of patients (control and treatment groups)
Clinical Phase III - answer✔✔Studies benefit/risk relationship of drug, less common/longer term
side effects, and labeling information on a very large group of patients
NDA - answer✔✔New Drug Application
Reasons for new drug failure - answer✔✔Pharmacokinetics (39%)
Lack of efficacy (30%)
Animal toxicity (11%)
Adverse effects in man (10%)
Commercial reasons (5%)
Other (5%)
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller Thebright. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $10.49. You're not tied to anything after your purchase.
