Podcast
Questions and Answers
What is the first stage in drug development?
What is the first stage in drug development?
- Drug discovery
- Post-clinical stage
- Clinical stage
- Preclinical stage (correct)
What expertise is typically involved in drug development?
What expertise is typically involved in drug development?
- Safety assessors (correct)
- Financial management
- Marketing
- Human resources
What is the focus of the clinical stage in drug development?
What is the focus of the clinical stage in drug development?
- Synthesizing new molecules
- Pharmacovigilance
- Clinical trials (correct)
- Target site identification
Which process involves understanding diseases and identifying target sites?
Which process involves understanding diseases and identifying target sites?
What area of expertise is responsible for ensuring drug safety in clinical trials?
What area of expertise is responsible for ensuring drug safety in clinical trials?
What is the purpose of regulatory affairs in the context of gene editing on humans?
What is the purpose of regulatory affairs in the context of gene editing on humans?
What is the role of the International Council on Harmonisation (ICH) in product approval regulations?
What is the role of the International Council on Harmonisation (ICH) in product approval regulations?
What is a common concern addressed by the 'Paediatric Investigation Plan' (PIP) requirement?
What is a common concern addressed by the 'Paediatric Investigation Plan' (PIP) requirement?
What does the term 'Snake oil' or 'Patent remedies' refer to in the context of medicinal products?
What does the term 'Snake oil' or 'Patent remedies' refer to in the context of medicinal products?
In what way do UK, EU, and FDA differ in their approach to clinical studies on pediatric medicines compared to historical practices?
In what way do UK, EU, and FDA differ in their approach to clinical studies on pediatric medicines compared to historical practices?
Why was it historically controversial to conduct clinical studies of new drugs in children?
Why was it historically controversial to conduct clinical studies of new drugs in children?
What is the purpose of Phase II clinical trials?
What is the purpose of Phase II clinical trials?
How many subject groups with different doses are usually included in a Phase II study design?
How many subject groups with different doses are usually included in a Phase II study design?
Which regulatory status is needed for Phase III clinical trials in Europe or the UK?
Which regulatory status is needed for Phase III clinical trials in Europe or the UK?
What is the primary focus of Phase I clinical trials?
What is the primary focus of Phase I clinical trials?
Where are Phase III clinical trials usually conducted?
Where are Phase III clinical trials usually conducted?
How many subjects typically participate in Phase I clinical trials?
How many subjects typically participate in Phase I clinical trials?
What is needed for Phase II clinical trials in the USA?
What is needed for Phase II clinical trials in the USA?
What is the primary purpose of Phase III clinical trials?
What is the primary purpose of Phase III clinical trials?
'Double-blind' refers to:
'Double-blind' refers to:
Flashcards
Drug Development Process
Drug Development Process
The coordinated steps to bring a new drug to market, including preclinical research, clinical trials, and post-market surveillance.
Preclinical Stage
Preclinical Stage
The initial stage involving disease understanding, target identification, molecule synthesis, and ADME-Tox testing.
Clinical Stage
Clinical Stage
Studies conducted in humans to assess the safety, efficacy, and optimal use of a drug.
Phase I Clinical Trials
Phase I Clinical Trials
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Phase II Clinical Trials
Phase II Clinical Trials
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Phase III Clinical Trials
Phase III Clinical Trials
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Phase IV Clinical Trials
Phase IV Clinical Trials
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Regulatory Affairs
Regulatory Affairs
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ICH
ICH
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Common Technical Document
Common Technical Document
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Paediatric Medicines
Paediatric Medicines
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Paediatric Investigation Plan (PIP)
Paediatric Investigation Plan (PIP)
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Study Notes
Drug Development Process
- The process involves preclinical, clinical, and post-clinical stages.
- Experts involved include basic research, safety assessors, research and development, clinical trials, regulatory affairs, and marketing.
Preclinical Stage
- Understanding disease, identifying target site, synthesizing and ADME pharmacological testing of molecules.
- Development of pharmaceutical products involves gene editing on humans and safety assessments.
Clinical Stage
- Safety studies, clinical trials (Stages I, II, III, and post-market studies).
- Clinical trials involve Phase I (non-therapeutic safety/tolerability), Phase II (therapeutic preliminary efficacy), and Phase III (crucial therapeutic).
Phase I Clinical Trials
- Purpose: Assess safety and tolerability of the IMP in humans.
- Timing: After 1 month Safety Assessment studies.
- Regulatory status: Needs Investigational New Drug Application (IND) in the USA and Clinical Trials Application (CTA) in Europe or UK.
- Subjects: Healthy volunteers and patients.
- Number: 50-200.
- Location: Conducted under full medical supervision in a hospital or clinical center.
Phase II Clinical Trials
- Purpose: Establish preliminary efficacy of the IMP in patients and effective range of doses.
- Timing: After Phase I studies and 6 month (rodent) and 9 month (non-rodent) Safety Assessment studies.
- Regulatory status: Needs new or updated IND in the USA and CTA in Europe or UK.
- Subjects: Patients with a defined disease and specific stage of disease progression.
- Number: 100s.
- Location: Conducted under full medical supervision in hospital or clinical centers.
Phase III Clinical Trials
- Purpose: Confirm efficacy of the IMP in patients, final selection of dose(s) for marketing, and relative efficacy to the market leader.
- Timing: After Phase II studies and DART and carcinogenicity Safety Assessment studies.
- Regulatory status: Needs new or updated IND in the USA and CTA in Europe or UK.
- Subjects: Patients with a defined disease and specific stage of disease progression.
- Number: 1000s.
- Location: Conducted under full medical supervision in hospital or clinical centers.
Phase IV Clinical Trials
- Purpose: Post-market surveillance to gain more experience in more patients.
- Timing: After approval and marketing.
- Study design: Various studies, including bioequivalence and safety assessments.
Regulatory Affairs
- Purpose: To safeguard public health and ensure medicinal products are safe, efficacious, and of suitable quality.
- International Council on Harmonisation (ICH) harmonizes regulatory requirements for product approval.
- ICH members: FDA, EU, Japan, and industry representatives.
- "Common Technical Document" for final approval.
Paediatric Medicines
- Historically, clinical studies of new drugs in children have been controversial and not usually performed.
- UK, EU, and FDA now require clinical studies in children with a "Paediatric Investigation Plan" (PIP) and "waiver" if no therapeutic application in children.
- 6 months extra patent protection granted for paediatric studies.
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