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Ricky Chang

Understand the science behind pharmaceutical drug discovery, drug development, and clinical trials. Whether you're expanding your career knowledge into the pharmaceutical industry or an aspiring pharmaceutical scientist or clinical project coordinator, you've come to the right place.

This course will give you an introductory understanding of the science behind how drug candidates are discovered and selected, how drugs are developed, the process of clinical trial, alternative medicine, generic and innovator drugs, regulatory affairs, and an overview of the pharmaceutical industry,

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Understand the science behind pharmaceutical drug discovery, drug development, and clinical trials. Whether you're expanding your career knowledge into the pharmaceutical industry or an aspiring pharmaceutical scientist or clinical project coordinator, you've come to the right place.

This course will give you an introductory understanding of the science behind how drug candidates are discovered and selected, how drugs are developed, the process of clinical trial, alternative medicine, generic and innovator drugs, regulatory affairs, and an overview of the pharmaceutical industry,

While most science courses focus on simply what the theories are, I teach through applicable, real-life examples designed to show you why these theories work and how they can be applied in your very own daily lives. I will not teach you to memorize formulas, theories, or to regurgitate facts and drug names. I will provide insights into the drug discovery and development through the lens of a pharmaceutical scientist or clinical project coordinator.

By the end of the course, you'll be able to:

  • Describe how drugs candidates are discovered, developed, put through clinical trial, and regulated

  • Explain the similarity and differences between generic and innovator (brand) drugs

  • Understand alternative and complementary medicine, what they are, why people use them, and how they "work"

  • Discuss the controversies surrounding "Big Pharma" and the biggest lawsuits surrounding pharmaceutical companies

  • Explain the theory of bioequivalence, narrow therapeutic drugs, regulatory requirements

  • Know the difference between pharmaceutical scientist, pharmacist, pharmacologists, toxicologists, doctors, and nurses

  • And many, many more.

The course will provide you with:

  • Instructional videos of course content

  • Lecture slides to go with the instructional videos

  • Downloadable technical resources

  • Quizzes to test your understanding

  • Lifetime access

  • Email and message support

Disclaimer:

The contents of this course "Introduction to Drug Discovery and Drug Development", including but not limited to text, graphics, images, and other material contained on Udemy (“Content”) are for informational purposes only. I do not intend the Content to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read or learned it on Udemy.

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What's inside

Learning objectives

  • Have insight into the pharmaceutical industry, pharmacy, and drug discovery and development process
  • Understand how drugs candidates are discovered, developed, put through clinical trial, and regulated
  • Know the similarity and differences between generic and innovator (brand) drugs
  • Alternative and complementary medicine, what they are, why people use them, and how they "work"
  • Decide for yourself the controversies surrounding "big pharma" and how they work
  • Learn how to think like a pharmaceutical scientist or a clinical project coordinator
  • Understand the difference between pharmaceutical scientist, pharmacist, pharmacologists, toxicologists, doctors, and nurses,
  • The theory of bioequivalence, narrow therapeutic drugs, regulatory requirements
  • And many, many more.....

Syllabus

Introduction to Drug Discovery and Development

In this introductory video, I will show the course outline and expectations for this course. What I intend to cover and what you will get out of the course!

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In this lesson, I will explain what is drug discovery, the definition of what a "drug" is, and discuss the term "lead compound".

In this lesson, I will briefly discuss the history of drug discovery and how we began exploring medicinal purpose in substances.

In this lesson, I will define what drug development is and outline the different components of the drug development process.

In this lesson, I will explain some basic pharmacological concepts, such as pharmacokinetics (PK) and pharmacodynamics (PD), and introduce the concept of ligand and target.

In this lesson, I will discuss the different ligand-target interactions. I will describe the various ligands: agonists, inhibitors, and allosteric modulators and how they act upon a target to give a particular response.

In this lesson, I will explain what happens exactly at different stages of drug discovery, and what scientific discipline is involved in contributing to each stage.

In this lesson, I will briefly talk about the various sources of drug candidates from nature that we might use as medicines. This does not enough just living things, but also inanimate objects.

In this lesson, I will quickly talk about how we can explore or discover drug candidates through synthetic means.

In this lesson, I will quickly explain what is virtual design or virtual screening, which is one way to discover drug candidates.

In this lesson, I will explain what are some things a pharmaceutical scientist might consider when designing a lead compound.

In this lesson, I will discuss what happens during the pre-clinical trial, what is the key takeaway, and what may be required by the government regulatory bodies.

In this lesson, I will discuss what happens during the Phase 0 and Phase 1 of the clinical trial, what is the key takeaway, and what may be required by the government regulatory bodies.

In this lesson, I will discuss what happens during the Phase 2 of the clinical trial, what is the key takeaway, and what may be required by the government regulatory bodies.

In this lesson, I will discuss what happens during the Phase 3 of the clinical trial, what is the key takeaway, and what may be required by the government regulatory bodies.

In this lesson, I will discuss what happens during the Phase 4 of the clinical trial, what is the key takeaway, and what may be required by the government regulatory bodies. I will end off the discussion with a summary of all the stages of clinical trial.

In this lesson, I will explain why we regulatory bodies, and what are some representative institutions in the various countries.

In this lesson, I will describe the five main types of drug applications: at which stage they should be submitted (if needed), and what is the purpose of each application.

In this lesson, I will discuss how much it cost for a drug to be discovered and developed, and what are some of the reasons drugs are so expensive.

In this lesson, I will talk about how pharmaceutical companies get their money, what's in it for them, and what are some incentives pharmaceutical companies have to do this costly research.

In this lesson, I will discuss the similarities and differences between innovator drugs and generic drugs, and in what case it may not be suitable to take.

In this lesson, I will discuss the safety of generic drugs and how regulatory bodies play a role in managing safety.

In this lesson, I will define biologics and subsequent entry biologics (SEBs) and why they are different from generic drugs.

In this lesson, I will describe the concept of bioequivalence - and why it is important in relation to generic drugs, manufacturing formula or process change, drug concentration over time, and narrow therapeutic drugs.

In this lesson, I will talk about the regulatory bodies' requirement to ensure generic drugs attain bioequivalence.

In this lesson, I will attempt to address any misconceptions or common myths surrounding generic drugs, often posed by the general public.

Not everything is perfect. In this lesson, I will discuss certain controversies surrounding generic drugs and how they happened. The key takeaway is to know that while there are certain incidents, overall generic drugs are very safe and these are quite rare occurrences.

In this lesson, I will explain what essential medicines are, some of its history, why does every country have a list for adult and children, and some considerations for how they are chosen.

In this lesson, I will define the term "Big Pharma" and raise some of the common questions and beliefs surrounding this entity.

In this lesson, I will attempt to address and debunk the "Big Pharma" conspiracy theory through fact-based, unbiased, stepwise logic. It is important to address these topics so the truth can prevail over misinformation.

In this lesson, I will discuss the dark side of pharmaceutical companies. As scientists, it is important to see evidence from both sides and leave no facts unchecked. As we talk about the conspiracy theory, we should also talk about the dark truth behind some of the incidents that occurred.

In this lesson, I will outline and detail the top ten biggest lawsuits and settlements on pharmaceutical companies.

In this lesson, I will describe the four major types of pharmaceutical companies that exist within the industry.

In this lesson, I will define the term "Alternative Medicine" and outline the challenges scientists have in discussing alternative medicines.

In this lesson, I will describe the various examples of alternative medicines and the NCCIH classification categories that alternatives medicines may be classified as.

In this lesson, I will discuss seven reasons why people use alternative medicines.

In this lesson, I will quickly talk about some issues and controversies surrounding alternative medicine and why the placebo effect plays a huge role in alternative medicine.

In this lesson, I will explain (in fairly extensive details) how complementary or alternative medicines "work" even when they don't actually work.

In this lesson, I will discuss the negative and positive things of using alternative medicine.

In this lesson, I will discuss the roles and responsibilities of pharmaceutical scientists.

In this lesson, I will discuss the roles and responsibilities of pharmacologists and toxicologists.

In this lesson, I will discuss the roles and responsibilities of pharmacists, doctors, and nurses.

You did it! CONGRATULATIONS!! You have finished this course. Don't forget to get your certificate. I sincerely wish you the best in all your future endeavors and thank you again for taking this incredible journey with me.

And if you're interested, feel free to check out my other course on Udemy called "Introduction to Pharmaceutics and Biopharmaceutics".

Traffic lights

Read about what's good
what should give you pause
and possible dealbreakers
Provides an overview of the pharmaceutical industry, which may be helpful for those looking to enter the field or understand its various facets
Explores the roles of pharmaceutical scientists, pharmacists, pharmacologists, toxicologists, doctors, and nurses, offering clarity on career paths
Examines the controversies surrounding "Big Pharma" and major lawsuits, providing a balanced perspective on the industry's challenges
Discusses alternative and complementary medicine, including reasons for use and how they "work", which may be at odds with scientific understanding
Requires learners to understand the differences between innovator drugs and generic drugs, and in what case it may not be suitable to take

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Reviews summary

Introductory drug discovery and development overview

According to students, this course provides a solid introduction and a comprehensive overview of the drug discovery and development process, from target identification through clinical trials and regulatory affairs. Many learners found the instructor's explanations clear and the content well-structured and easy to follow, making complex topics accessible. The course is frequently described as excellent for beginners or those seeking a general understanding of the pharmaceutical industry. Some reviews highlight the coverage of regulatory bodies, generic vs. innovator drugs, and even alternative medicine as valuable additions. Quizzes are mentioned as helpful for checking understanding. While praised for its breadth, a few learners noted that it is strictly an introduction and may require further study for in-depth knowledge.
Assessments help check understanding.
"The quizzes were helpful for testing my knowledge."
"I liked the quizzes at the end of each section to reinforce learning."
"Quizzes were a good way to consolidate information."
"Useful checks on understanding after each major topic."
Includes relevant adjacent topics like regulatory bodies.
"I appreciated the sections on regulatory bodies and generic drugs."
"The module on alternative medicine was unexpectedly interesting."
"It covers not just the science but also the regulatory and cost aspects."
"Nice addition of topics like Big Pharma controversies and essential medicines."
Course is organized logically and easy to follow.
"The course structure is well organized and easy to follow."
"Content delivery was systematic and helped build understanding step by step."
"The flow from one topic to the next felt natural and logical."
"Organized in a way that makes learning efficient."
Instructor explains concepts clearly and effectively.
"The instructor is very good and explains the concepts in a simple and clear manner."
"The course content is well explained and very easy to grasp."
"Concepts were broken down logically and explained well."
"The clarity of the lectures helped me follow along easily."
Covers all key stages of the drug lifecycle.
"The course covers end-to-end process, which is very helpful."
"Good comprehensive overview of the whole process from discovery to market."
"I liked that it touched upon many relevant aspects of the industry."
"Provides a good scope of the process, covering pre-clinical, clinical, and regulatory."
Provides a clear and accessible starting point.
"It was really introductory and gave me a good basic understanding of the whole process."
"Excellent course, good for beginners, instructor made it easy to follow complex topics."
"This course serves as a great introduction to drug discovery & development."
"Really helpful for understanding the basics before diving deeper into the field."
Strictly introductory, not suitable for advanced learners.
"Good introductory course but doesn't go into much detail for someone with prior background."
"As stated, it's an 'Introduction', so expect breadth over depth."
"If you're looking for deep scientific dives, this might not be it."
"Provides a foundation but you'll need other resources for specialization."

Activities

Be better prepared before your course. Deepen your understanding during and after it. Supplement your coursework and achieve mastery of the topics covered in Introduction to Drug Discovery and Drug Development with these activities:
Review Basic Pharmacology Concepts
Reinforce your understanding of fundamental pharmacology concepts like pharmacokinetics, pharmacodynamics, and ligand-target interactions to better grasp how drugs work within the body.
Browse courses on Pharmacokinetics
Show steps
  • Review definitions of pharmacokinetics and pharmacodynamics.
  • Explain the different types of ligand-target interactions.
  • Summarize the roles of agonists, inhibitors, and allosteric modulators.
Read 'The Emperor of All Maladies: A Biography of Cancer'
Gain a deeper understanding of the history and challenges of cancer treatment, providing context for drug discovery efforts in oncology.
Show steps
  • Read the book, focusing on the history of cancer treatment.
  • Take notes on key discoveries and setbacks in cancer research.
  • Reflect on how the history of cancer treatment informs current drug development strategies.
Compile a List of Regulatory Resources
Create a comprehensive list of resources related to pharmaceutical regulations, including websites, publications, and databases, to aid in understanding the regulatory landscape.
Show steps
  • Identify key regulatory bodies (e.g., FDA, EMA).
  • Gather links to their official websites and publications.
  • Include relevant databases and resources for regulatory information.
  • Organize the resources into a user-friendly list.
Three other activities
Expand to see all activities and additional details
Show all six activities
Create a Presentation on a Specific Drug Class
Deepen your understanding of a specific drug class by researching its mechanism of action, development history, clinical uses, and potential side effects, then presenting your findings.
Show steps
  • Choose a drug class (e.g., statins, ACE inhibitors, SSRIs).
  • Research the drug class's mechanism of action and development history.
  • Summarize the clinical uses and potential side effects.
  • Create a presentation summarizing your findings.
Read 'Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients'
Gain a critical perspective on the pharmaceutical industry and the controversies surrounding drug development and marketing.
View Bad Pharma on Amazon
Show steps
  • Read the book, focusing on the ethical issues discussed.
  • Take notes on examples of misleading practices by pharmaceutical companies.
  • Reflect on the implications of these practices for patient safety and public health.
Design a Hypothetical Clinical Trial
Apply your knowledge of clinical trial phases by designing a hypothetical trial for a new drug, including defining the target population, endpoints, and study design.
Show steps
  • Choose a disease and a hypothetical drug to treat it.
  • Define the target population and inclusion/exclusion criteria.
  • Design the clinical trial protocol, including phases and endpoints.
  • Outline the data collection and analysis plan.

Career center

Learners who complete Introduction to Drug Discovery and Drug Development will develop knowledge and skills that may be useful to these careers:
Pharmaceutical Scientist
A Pharmaceutical Scientist engages in drug discovery and development. This course is designed to provide insights into how drug candidates are discovered, selected, and developed. It provides context on the scientific disciplines involved in each stage of drug discovery. Learning about pharmacokinetics, pharmacodynamics, and ligand-target interactions will help you to work in this role. It is tailored to give you the perspective of a pharmaceutical scientist, making that aspect of the curriculum particularly beneficial.
Clinical Project Coordinator
The Clinical Project Coordinator is responsible for the administrative and logistical aspects of a clinical trial. This course helps you better understand the clinical trial process, from start to finish. The course covers the different phases of clinical trials and gives some context on what is required by regulatory bodies. Understanding the clinical trial process is critical for a clinical project coordinator. This course is particularly relevant for those aspiring to such a role.
Clinical Research Associate
A Clinical Research Associate plays a critical role in managing and monitoring clinical trials. This course provides a strong foundation in understanding the phases of clinical trials, from pre-clinical through phase four, and the regulatory requirements for each. This introduction is essential for a clinical research associate seeking to ensure trials are conducted ethically and accurately. The course's discussion of drug development and regulatory bodies makes it particularly helpful for aspiring clinical research associates.
Pharmacologist
A pharmacologist studies the effects of drugs on the body. This course provides information about drug discovery, development, and clinical trial processes. It also covers pharmacokinetics and pharmacodynamics, which are core concepts for this field. The course may help pharmacologists better understand the processes involved in bringing new medications to market. The course also covers various concepts related to the roles of pharmacologists.
Research Scientist
A research scientist is responsible for designing and conducting experiments to advance scientific knowledge. This course helps provide a foundational understanding of the drug discovery process. It covers the stages of drug discovery and the various scientific disciplines involved. This is especially useful when you are involved in drug discovery research. The course's focus on real-life examples helps build conceptual knowledge for aspiring scientists.
Toxicologist
A toxicologist studies the adverse effects of chemicals, including pharmaceuticals, on living organisms. The course's discussion of drug discovery and development may be useful for a toxicologist. The course also includes a section that addresses the roles and responsibilities of a toxicologist. This course may help individuals seeking a role as toxicologist better understand basic concepts related to the impact of chemical substance.
Regulatory Affairs Specialist
A Regulatory Affairs Specialist is responsible for ensuring that pharmaceutical products meet regulatory standards. This course may help to build an understanding of the different regulatory bodies and the various types of drug applications. The course also covers topics such as bioequivalence and regulatory requirements, which are crucial for anyone working in regulatory affairs. The course emphasizes the importance of regulatory compliance and provides relevant information that a regulatory affairs specialist will find insightful.
Biotechnology Research Associate
A biotechnology research associate assists in research and development within the biotechnology industry, often working on the development of new therapies. This course may be useful in developing a foundational understanding of the drug discovery process, clinical trials, and regulatory requirements. The course is designed to provide individuals with the insights and knowledge necessary to navigate the industry. The course's focus on real-life examples may help you apply these concepts in your research.
Pharmacovigilance Specialist
A pharmacovigilance specialist monitors the safety of pharmaceutical products and related adverse events. This course may be helpful as it covers clinical trials, post-market surveillance, and the regulatory environment. The course provides a background that is useful in understanding how drugs are developed and regulated. Its discussion of clinical trials and regulatory requirements may be helpful for those interested in pursuing a career in pharmacovigilance.
Medical Science Liaison
A Medical Science Liaison builds relationships with key opinion leaders and provides scientific expertise on pharmaceutical products. This course may be useful in building your knowledge of the drug development process, the difference between generic and innovator drugs, and the clinical trial process. The course's overview of the pharmaceutical industry and its controversies will help hone your scientific acumen. It is useful in gaining a better understanding of the science behind medications, which will allow you to better communicate with stakeholders.
Quality Control Analyst
A Quality Control Analyst ensures the quality of pharmaceutical products by testing them at different stages of the manufacturing process. This course covers regulatory bodies, bioequivalence, and the difference between generic and innovator drugs, all of which are relevant to a quality control analyst's duties. A quality control analyst must be familiar with the key concepts discussed in this course. This course provides an overview of concepts that analysts apply in their daily work.
Medical Writer
A medical writer creates documents related to pharmaceutical products, including regulatory submissions, clinical trial reports, and marketing materials. This course may be useful in helping those interested in scientific writing to better understand drug discovery and development. The course may also assist in developing an understanding of the scientific and regulatory aspects of the pharmaceutical industry. This course lays the groundwork for individuals who need a basic understanding of the science behind drugs.
Pharmaceutical Sales Representative
A pharmaceutical sales representative promotes and sells pharmaceutical products to healthcare professionals. This course helps you to understand the science behind the drugs you're selling. It provides insights into drug discovery, development, and clinical trials, and the difference between generic and innovator drugs. This course may be helpful in understanding the science behind the products these sales professionals represent, as well as the regulatory environment. This overview helps the sales representative better communicate with physicians and other healthcare professionals.
Science Journalist
A Science Journalist communicates scientific topics to the public. This course may help a science journalist better understand the drug discovery and development process, as well as the controversies surrounding pharmaceutical companies. The course's overview of the pharmaceutical industry, clinical trials, and the differences between generic and innovator drugs may provide context. The course's coverage of alternative medicine may also be useful to those seeking to report to the public on health-related topics. This fundamental knowledge may be useful for science journalists.
Health Science Educator
A Health Science Educator teaches health-related topics, often in academic or training settings. This course is useful in understanding the complexities of drug discovery and development. It may help educators to stay current on the latest pharmaceutical industry concepts. The course's overview of the pharmaceutical industry, clinical trials, and regulatory affairs may be helpful for instructors. It gives a comprehensive introduction that will help them share this information with their students.

Reading list

We've selected two books that we think will supplement your learning. Use these to develop background knowledge, enrich your coursework, and gain a deeper understanding of the topics covered in Introduction to Drug Discovery and Drug Development.
Critically examines the practices of pharmaceutical companies, including issues related to clinical trial transparency, data manipulation, and marketing tactics. It provides a balanced perspective on the controversies surrounding 'Big Pharma' discussed in the course. This book is valuable as additional reading to provide a critical perspective on the pharmaceutical industry.
This Pulitzer Prize-winning book provides a comprehensive history of cancer research and treatment. It offers valuable context for understanding the challenges and triumphs in drug discovery and development related to oncology. While not directly focused on drug development, it provides a deep understanding of the disease itself, which is crucial for anyone in the field. is more valuable as additional reading to provide a historical and scientific context.

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