Pharmacology: Drug Receptors and Ligand-Receptor Model

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Questions and Answers

What is the main outcome you want in a product according to the text?

Safety

How can you determine 'bad quality' of a product according to the text?

Only afterwards

Which tragic event is mentioned in the text related to the year 1937?

Sulfanilamide Elixir tragedy

Which element is NOT listed as an essential component of drug quality in the text?

Quantity Signup and view all the answers

In what year was the Pediatric Equity Act introduced according to the text?

2003 Signup and view all the answers

What is a major concern highlighted in the text regarding drug safety?

Contaminated cough syrup incidents in various countries Signup and view all the answers

What are the two ways to study in the context of pre-clinical testing?

In vivo and in vitro Signup and view all the answers

Which phase of clinical trials is known as 'First in Humans' and focuses on assessing the drug's safety?

Phase I Signup and view all the answers

What is the main objective of Phase II clinical trials?

Study efficacy and side effects of the drug Signup and view all the answers

What is a common key stage in clinical trials focusing on confirming efficacy and involving comparison with other treatments?

Phase III Signup and view all the answers

In pre-clinical testing, what is the main focus when studying drug-drug or food-drug interactions?

Assessing safety or toxicity Signup and view all the answers

What type of studies are conducted during Phase IIb of clinical trials?

Dose-ranging studies Signup and view all the answers

What is the term used to describe how well a drug binds to its receptor?

Affinity Signup and view all the answers

What is the end point for life-threatening diseases in clinical trials?

Survival Signup and view all the answers

Which type of receptors make up the largest family of receptors?

G protein-coupled receptors Signup and view all the answers

In clinical trials, which type of design involves neither the doctor nor the patient knowing what is being given?

Double blinded, randomized design Signup and view all the answers

What do enzyme associated receptors convert extracellular signals into inside the cell?

Enzyme activity Signup and view all the answers

What do ion channels and transporters do when activated by receptors?

Open an ion channel for ion passage Signup and view all the answers

What type of design involves studying multiple factors including existing, complementary, and competing treatments along with a placebo?

Factorial design Signup and view all the answers

Which phase of pharmacovigilance involves reporting adverse reactions after a drug is already on the market?

Phase IV Signup and view all the answers

Which type of receptors impact how genetic messages are interpreted or transcribed?

Transcriptional regulators & nuclear hormone receptors Signup and view all the answers

What signals can lead to stopping the marketing of a drug in Phase IV of clinical trials?

Safety signals Signup and view all the answers

Why is having affinity important in the ligand-receptor interaction?

To guarantee the intended effect of the drug Signup and view all the answers

In trial design, what is the purpose of double blinding and randomization?

To reduce extraneous variables and isolate drug-related outcomes Signup and view all the answers

What should we consider when thinking about ethical questions in the pharmaceutical industry?

The right of patients to access medical treatment Signup and view all the answers

Why is it important to think about affordability in healthcare?

To ensure that healthcare is accessible to all socio-economic groups Signup and view all the answers

Who are considered as stakeholders in the pharmaceutical industry?

Patients, payers, government, and society Signup and view all the answers

In clinical trials, what does the use of a placebo often signify?

That patients are not receiving the actual medication being tested Signup and view all the answers

Why are patients sometimes considered vulnerable in the pharmaceutical industry?

Because they may not always be informed or knowledgeable Signup and view all the answers

What aspect plays a significant role in determining if a patient can truly have a choice in medical treatment?

Whether they have access to information and are informed Signup and view all the answers

Study Notes

Clinical trials aim to assess factors like absence of disease, decreased pain, and survival for life-threatening diseases as endpoints.
Phase IV involves surveillance for risk/benefit, where safety signals can lead to stopping marketing, and sometimes even efficacy.
Trial design involves statistical methods to remove extraneous variables, isolate drug-related outcomes, and ensure blinding and randomization.
Pharmacovigilance includes adverse reaction reporting post-market, with a focus on drug safety and quality over the product's shelf life.
History of regulations highlights past tragedies like the Sulfanilamide Elixir and Thalidomide disasters, leading to stringent quality and safety standards.
Stakeholders in drug development include patients, payers, government, and society, with a focus on ethical considerations, affordability, and patient choice.
Preclinical testing involves assessing drug safety in animals through in vitro and in vivo studies before proceeding to Phase I clinical trials.
Clinical trials progress through Phase I (safety), Phase II (efficacy and safety), and Phase III (confirming efficacy) before seeking regulatory approval.
Phase III trials focus on clinical endpoints to demonstrate direct clinical benefit of the drug, with a defined protocol and comparison with placebos.

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