Pharmaceutical Research Module Quiz

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Questions and Answers

What is the purpose of the hit discovery process?

To evaluate the safety of a drug candidate

To synthesize known drugs

To screen for compounds with the desired activity (correct)

To develop new therapeutic strategies

Which method is NOT mentioned as part of the hit discovery process?

High-throughput screening

Computer-aided structure-based drug design

Natural extracts screening

Patient-derived testing (correct)

What is a lead compound?

A chemical compound that has been abandoned

Any compound that has undergone structural modifications

A compound that shows minimal therapeutic potential

A chemical compound that shows promise for treating a disease (correct)

What is the primary focus of lead optimization?

Improving potency and physicochemical properties Signup and view all the answers

What does SAR stand for in the context of drug development?

Structure-Activity Relationship Signup and view all the answers

Which of the following modifications is NOT a systematic approach mentioned?

Natural product extraction Signup and view all the answers

In the hit discovery process, which screening method allows for the evaluation of many compounds?

High-throughput screening Signup and view all the answers

What characterizes a hit compound in drug discovery?

It shows the desired type of activity in assays. Signup and view all the answers

What is one reason why aspirin might lose its potency when stored improperly?

Moisture Signup and view all the answers

Which of the following composes the basic structure of organic chemistry?

Carbon compounds Signup and view all the answers

In the context of drug design, what do the terms 'hit' and 'lead' refer to?

The discovery of a potential drug and its further optimization Signup and view all the answers

What is an important aspect of understanding reaction kinetics in chemistry?

Determining the mechanism of a reaction Signup and view all the answers

What is the role of enzymes in drug interactions?

To speed up reaction rates Signup and view all the answers

Which of the following is a key factor influencing drug solubility?

Lipophilicity Signup and view all the answers

Why is thermodynamics important in the study of chemistry?

It explains the energy changes associated with chemical reactions Signup and view all the answers

What is the primary goal of in vitro assays conducted during preclinical research?

To study drug toxicity and off-target effects Signup and view all the answers

What is a practical implication of knowledge in spectroscopy in chemistry?

Analyzing the composition of substances Signup and view all the answers

Which of the following accurately describes the purpose of Phase I clinical trials?

To assess the drug's safety and pharmacokinetics in healthy volunteers Signup and view all the answers

Which component is NOT part of the in vivo ADME process during drug development?

Manufacturing of drug dosage forms Signup and view all the answers

What is the expected probability of a drug entering Phase II clinical trials?

66.4% Signup and view all the answers

Which route of administration is NOT mentioned as a method to prevent drug interaction with healthy tissues?

Transdermal delivery Signup and view all the answers

What is the primary focus of Phase III clinical trials?

Assess drug safety and overall benefit-risk relationship Signup and view all the answers

During preclinical research, lead compounds are tested on which of the following?

Non-human subjects in in vivo animal models Signup and view all the answers

How long does clinical development typically take, from the selection of potential drug candidates to market?

3-5 years Signup and view all the answers

What is the probability of drugs being approved during clinical trials?

59% Signup and view all the answers

Which factor is NOT a common reason for failure in clinical trials?

High efficacy Signup and view all the answers

Which regulatory agency is responsible for drug approval in the USA?

FDA Signup and view all the answers

What percentage decline in clinical trial starts was observed in 2023 compared to 2022?

15% Signup and view all the answers

How many novel active substances (NAS) were launched globally in 2023?

69 Signup and view all the answers

What was a contributing factor to the decline in clinical trial starts in 2023?

COVID-19 trials decline Signup and view all the answers

Which statement is accurate regarding the approval process for new drugs?

2 out of 5 drugs that reach Phase III fail to win approval. Signup and view all the answers

What aspect of drug development is NOT typically assessed during clinical trials?

Patient comfort Signup and view all the answers

What percentage of new product launches in the past five years were in oncology, neurology, and immunology?

56% Signup and view all the answers

What does the composite success rate in drug R&D indicate for 2023?

Increased to 10.8% Signup and view all the answers

Which of the following is NOT a category included in infectious diseases treatments mentioned?

Anti-inflammatory Signup and view all the answers

What is the main purpose of post-marketing monitoring?

To monitor the safety of approved drugs Signup and view all the answers

How many drugs have been recalled from the market according to the information provided?

More than 500 Signup and view all the answers

During which phase are healthy volunteers assessed for safety and pharmacokinetics?

Phase I Signup and view all the answers

Which substance was noted for causing serious hepatotoxicity leading to liver transplant or death?

Alatrofloxacin Signup and view all the answers

Which step is part of the correct drug development process sequence?

Pre-clinical Signup and view all the answers

Study Notes

Drugs and Medicines PMP-102

The lecture covers the long journey from molecule to medicines.
The lecturer, Dr. Salvatore Ferla, is associated with Swansea University.

About Myself (Salvo)

Holds a Master's Degree in Medicinal Chemistry (2008).
Was a co-supervisor of Pharmaceutical Production (QA, GMP) from 2008-2009.
Registered as a qualified pharmacist since 2008.
Earned a PhD in Medicinal Chemistry (2009-2013).
Worked as a Research Associate in Medicinal Chemistry/Drug Design (2013-2018).
Worked as a Research Fellow in Medicinal Chemistry/Drug Design (2018-2020).
Served as a Lecturer in Pharmaceutical Chemistry (2020-2023).
Became a Senior Lecturer in Pharmaceutical Chemistry (2023-present).

About My Work

Specialises in Pharmaceutical Chemistry, Organic Chemistry, Medicinal Chemistry, Drug Discovery, and Molecular Modelling.
Develops computer-aided techniques and organic chemistry methods to identify new small molecules that target biological targets. This includes activities against cancer, viruses, or other targets.

How Will We Learn Together?

The module uses a flipped classroom model.
Students review pre-class videos on Canvas.
Students take formative quizzes on Canvas.
Students participate in live sessions (F2F or Zoom) for discussions, questions, and answers.
Students actively participate and prepare for final exams.

What Will We Learn?

Basic Concepts: Acid/base, pH, solubility, lipophilicity, thermodynamics, reaction kinetics, and practical chemistry.
Advanced Concepts: Carbon compounds, functional groups, spectroscopy techniques (spectrometry), enzymes, receptors, nucleic acids, other targets, basic drug design, drug-like properties, and hit and lead.
Organic Chemistry: Focus on organic chemistry concepts relevant to drugs and medicinal chemistry.
Drugs and Drug Targets: Explore the nature of drugs and their interactions with the body's target molecules.

Why Do We Need to Study Chemistry?

A patient left an aspirin bottle open in a bathroom cabinet.
Pharmacist A checked the leaflet, which advised keeping the bottle tightly closed and below 25°C, and instructed the patient to discard the medicine.
Pharmacist B explained the reason aspirin's instability in the bathroom could lessen its effectiveness.
Patients reacted differently, one distrustful of the advice, and the other accepting it.
Illustrates the importance of understanding chemical properties like moisture sensitivity and temperature stability for effective drug use.

Learning Outcomes

Describe the major components of medicines.
Discuss the steps involved in the development of a medicine.
Describe the constituents of medicines.
Understand the key steps in drug discovery and development.

Do I Know the Answer?

Questions the student should answer relate to HIT COMPOUND definition, PHASE I CLINICAL PHASE definition, and the correct sequence for DRUG DEVELOPMENT PROCESS.

Drug or Medicine?

A distinction is made between drugs and medicines, with drugs as chemical substances used for diagnosing, treating, or preventing diseases, while medicines can be considered a delivery system for drugs.
Examples of drugs include 2-acetoxybenzoic acid, Agumentin, Ketoprofen, Ibuprofen 400mg, and Ampicillin.

Medicines Contain...

Excipients: These are substances in medicines that are not pharmacologically active but are crucial for medication delivery; these are often chemically inert. These include fillers, binders, disintegrants, glidants, colouring agents, antiadherants, lubricants, coatings, preservatives, etc.

How Long Does It Take?

Drug development to market typically takes 5 to 20 years.

Drug Development Process

The process is described through stages: in vitro and in vivo testing, human testing, data review, surveillance, basic/early research, discovery/development, phase I to phase III clinical development, pre-clinical, review, and finally post market monitoring to maintain and monitor safety.

Discovery & Development

In the past: active ingredients often came from traditional medicines, by chance.
Now, active compounds are targeted: screening hits, medicinal chemistry, etc.
Steps describe how new drug targets are found, validated, structure activity relationships (SAR) are established etc.

Preclinical Research

Lead compounds are tested on non-human subjects to assess safety, toxicity, and pharmacokinetics.
In vitro models evaluate drug activity and off-target effects.
In vivo tests involve various animal models studying bioavailability, dosage etc.
Best dosage is calculated for safety and proper administration routes.
Appropriate formulation is designed to maximize drug delivery without harming healthy tissues.

Clinical Development

Clinical trials include healthy and patient volunteers to evaluate safety, efficacy, and optimal dosage.
Phases I to III describe progress involving dosage ranges, safety checks, and efficacy testing.
Issues during testing (toxicity, lack of efficacy, drug interactions) can cause trials to be stopped.

Review (Licensing approval)

Regulators such as FDA, EMA, etc., review clinical trial data and approve or reject a new drug based on approval criteria and evidence.
Failure rates are high.

Post-Marketing Monitoring (Phase IV)

Post-approval monitoring addresses ongoing safety issues and potential risks.
Manufacturers are obligated to continuously review the long-term impact on the human body.
Safety issues discovered cause drug recalls to prevent adverse consequences.

In Summary...

The steps in discovering a new drug, testing at different phases, and the required monitoring of the drug after approval are explained.
The difference between a drug and a medicine is described.
The importance of chemistry in pharmacy/drugs is highlighted.

Now I know the answer...

Answers the commonly asked questions about hit compounds (a molecule that shows desired activity), phase I clinical trials (involving roughly 100 healthy volunteers to test safety and pharmacokinetics), and the accurate sequence of drug development stages.

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Description

Test your knowledge on Dr. Ferla's research methodologies and the structure of his course. This quiz covers key components such as teaching methods, drug targets, and the hit discovery process. Perfect for students studying pharmaceutical chemistry.