Podcast
Questions and Answers
How long does it generally take to develop a new medicine?
How long does it generally take to develop a new medicine?
- 12 years (correct)
- 5 years
- 8 years
- 15 years
What is the average cost of developing a new medicine?
What is the average cost of developing a new medicine?
- £250 million
- £1 billion
- £750 million
- £500 million (correct)
At which stage of drug development is the selection of 'hits' crucial?
At which stage of drug development is the selection of 'hits' crucial?
- Candidate selection
- Hit to lead (correct)
- Screen compound library
- Clinical phases
What is one of the main components in the process of developing pharmaceuticals?
What is one of the main components in the process of developing pharmaceuticals?
What is the average daily cost incurred during the development of a new medicine?
What is the average daily cost incurred during the development of a new medicine?
What phase follows 'Lead to Candidate' in the drug development process?
What phase follows 'Lead to Candidate' in the drug development process?
Which type of scientists are involved in the new medicine development process?
Which type of scientists are involved in the new medicine development process?
In the pharmaceutical development process, what is primarily needed during analysis?
In the pharmaceutical development process, what is primarily needed during analysis?
What do pharmacopoeias primarily provide guidelines for?
What do pharmacopoeias primarily provide guidelines for?
Which of the following is NOT a focus area when assessing a marketed pharmaceutical product?
Which of the following is NOT a focus area when assessing a marketed pharmaceutical product?
What are SFFC medicines commonly associated with?
What are SFFC medicines commonly associated with?
Which of the following product attributes is monitored for finished pharmaceutical preparations?
Which of the following product attributes is monitored for finished pharmaceutical preparations?
What is a potential consequence of using counterfeit medicines?
What is a potential consequence of using counterfeit medicines?
In terms of raw materials, what aspect do pharmacopoeias address?
In terms of raw materials, what aspect do pharmacopoeias address?
What is a major concern related to counterfeiting in pharmaceuticals?
What is a major concern related to counterfeiting in pharmaceuticals?
Which of the following describes a critical requirement for pharmaceutical formulations?
Which of the following describes a critical requirement for pharmaceutical formulations?
What is included in the marketing authorisation document for a drug?
What is included in the marketing authorisation document for a drug?
Which of the following is NOT a component of the Quality Assurance system in pharmaceutical manufacturing?
Which of the following is NOT a component of the Quality Assurance system in pharmaceutical manufacturing?
What is the purpose of regulatory authorities such as the FDA and EMA?
What is the purpose of regulatory authorities such as the FDA and EMA?
Which document is essential for pharmaceuticals to obtain a marketing authorisation?
Which document is essential for pharmaceuticals to obtain a marketing authorisation?
What do pharmacopoeias provide for pharmaceutical products?
What do pharmacopoeias provide for pharmaceutical products?
Which organization is responsible for inspecting pharmaceutical manufacturers to ensure compliance with regulations?
Which organization is responsible for inspecting pharmaceutical manufacturers to ensure compliance with regulations?
What is the primary focus of understanding the mechanism of degradation products in pharmaceuticals?
What is the primary focus of understanding the mechanism of degradation products in pharmaceuticals?
Which of the following practices does NOT contribute to quality in pharmaceutical manufacturing?
Which of the following practices does NOT contribute to quality in pharmaceutical manufacturing?
What is a common characteristic of counterfeit medicines?
What is a common characteristic of counterfeit medicines?
What was the significant issue with the counterfeit Avastin reported in 2012?
What was the significant issue with the counterfeit Avastin reported in 2012?
Which of the following is a potential indicator of a counterfeit drug?
Which of the following is a potential indicator of a counterfeit drug?
What did the FDA find in the counterfeit version of Alli during preliminary tests?
What did the FDA find in the counterfeit version of Alli during preliminary tests?
Why is it important to verify the appearance of a drug?
Why is it important to verify the appearance of a drug?
What is one of the health risks associated with counterfeit medications?
What is one of the health risks associated with counterfeit medications?
Which of the following packaging features might help identify a counterfeit medication?
Which of the following packaging features might help identify a counterfeit medication?
How can counterfeit packaging appear misleading?
How can counterfeit packaging appear misleading?
What is the primary action of Orlistat in the treatment of obesity?
What is the primary action of Orlistat in the treatment of obesity?
What significant risk is associated with the use of Orlistat?
What significant risk is associated with the use of Orlistat?
What percentage of patients experienced cardiovascular events while using Sibutramine?
What percentage of patients experienced cardiovascular events while using Sibutramine?
Why was Sibutramine withdrawn from the market?
Why was Sibutramine withdrawn from the market?
Which analytical technique is NOT mentioned for identifying active pharmaceutical ingredients?
Which analytical technique is NOT mentioned for identifying active pharmaceutical ingredients?
What type of drug is Orlistat categorized as?
What type of drug is Orlistat categorized as?
What is one of the unpleasant effects associated with Sibutramine?
What is one of the unpleasant effects associated with Sibutramine?
Which method is employed for physical analysis of pharmaceutical products?
Which method is employed for physical analysis of pharmaceutical products?
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Study Notes
Introduction to Pharmaceutical Analysis
-
Pharmaceutical research and development often takes 12 years and costs around £500 million.
-
A drug's journey from research and development to market launch involves numerous stages:
- Library screening
- Hit to lead stage
- Lead to candidate stage
- Candidate selection
- Clinical trials (Phase I to III)
- File and launch
Research & Development
-
Analytical techniques are critical in each stage of pharmaceutical research and development.
-
Analytical techniques evaluate the structure, purity, stability and properties of compounds:
- Are the structures correctly identified?
- How stable are the compounds over time?
- Analysis of degradation products to understand mechanisms of degradation
Obtaining a Marketing Authorization
- A product license is required for all drugs, and it is a comprehensive documentation containing:
- Clinical evidence demonstrating the drug's effectiveness and safety
- Description of the manufacturing process
- Data from studies supporting the quality, purity and shelf life of the drug
Manufacture Authorization
- All pharmaceutical companies require manufacture authorization.
- This ensures only authorized manufacturers produce licensed products.
- Authorities conduct regular inspections to ensure compliance with good manufacturing practices (GMP), quality assurance (QA), good laboratory practices (GLP), and quality control (QC).
Pharmacopoeias
- Published standards (monographs) for pharmaceutical products and raw materials.
- Examples:
- European Pharmacopoeia (Ph.Eur.)
- United States Pharmacopoeia (USP)
- British Pharmacopoeia (BP)
Pharmacopoeia Guidelines
- Outline requirements for:
- Purity of raw materials (standards)
- Methods for controlling raw materials
- Pharmaceutical formulations (dosage forms)
- Finished preparations (e.g., vaccines)
Questions regarding Marketed Drugs
- Analytical techniques evaluate:
- Quality of each batch
- Continuity of supply
- Patent protection
- Counterfeiting
- Customer complaints regarding quality or effectiveness
- Patient safety concerns
Counterfeiting – Key facts
- Counterfeit medicine is deliberately mislabeled with respect to identity or source.
- Counterfeiting can lead:
- Treatment failure
- Death
- Erosion of public confidence in healthcare systems
- Both generic and branded medicines are subject to counterfeiting.
- All kinds of drugs have been counterfeited.
Counterfeiting – Mislabeling
- Counterfeiting can involve:
- Use of correct ingredients, wrong ingredients, or no active ingredients
- Insufficient or excessive active ingredients
- Fake packaging
Counterfeit Drug Examples
-
Avastin (cancer treatment):
- Counterfeit batches lacked the active ingredient
-
Alli (weight-loss medicine):
- Counterfeit batches were smuggled and contained undeclared active ingredients
- These undeclared ingredients posed serious health risks to consumers
Identifying Counterfeit Drugs
- Package and appearance help to identify counterfeit drugs:
- Misspelling or missing LOT codes
- Irregular expiration dates
- Incorrect pill color or markings
- Presence of powder instead of pellets in capsules
Analysis Techniques for Counterfeiting
-
Visual Inspection: Analyzing packaging and tablets with microscopes.
-
Chemical Analysis:
- Identifies the presence/absence of active pharmaceutical ingredients using:
- Mass spectrometry (MS)
- Nuclear magnetic resonance (NMR)
- Infrared spectroscopy (IR)
- Identifies excipients in formulations using:
- MS, NMR, IR
- Elemental mapping on tablet surfaces
- Identifies the presence/absence of active pharmaceutical ingredients using:
-
Physical Analysis:
- Measures particle size.
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