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PY366 Drug discovery > Product design strategies > Flashcards

Product design strategies Flashcards

1
Q

what are the regulatory controls that need to be put in place for drug product development

A
  1. good laboratory practice (GLP)- non clinical regulatory work
  2. good manufacturing practice (GMP)- preclinical and clinical manufacture of both API and drug product
  3. good clinical practice (GCP)
  4. quality assurance and quality control
  5. qualified person- legally responsible for audit and release of API/product into market for human use
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2
Q

what steps are needed before developing a new drug product

A
  1. understand the market environment
  2. develop therapies to see unmet medical and realised market needs
  3. start with the end in mind and develop a plan
  4. understand the financial implication
  5. factor in the risks
  6. build exit strategy
  7. create product plan
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3
Q

outline the strategic planning approach

A
  1. market mapping/prioritisation
  2. define success
  3. develop TPP
  4. manufacturing and formulation strategy
  5. clinical development strategy
  6. financial projections
  7. exit strategy
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4
Q

what is involved in understanding the market needs

A
  1. Market mapping
    - patient prevelence
    - patient diagnosis/undiagnosed patients
    - patient category (high/low risk)
    - current therapies in use
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5
Q

what are the targets for a new product

A
  1. efficacy
  2. ease of administration
  3. greater patient compliance
  4. well tolerated therapy, minimal side effects
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6
Q

what is the primary barrier to new drug products

A
  1. rate limiting steps
    - need to see compelling data before switching to new therapy
    - stage of disease condition for effective treatment
    - cost effectiveness of treatment
    - prior data on earlier newer therapies and their effectiveness
    - extensive data collection (time consuming)
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7
Q

what is the unique value proposition for market segment

A
  1. identify important and different features and benefits compared to other products
  2. sustainable and should help in product trial and usage
  3. create TPP to highlight and drive product development and clinical testing to demonstrate benefits
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8
Q

what is involved in the prioritisation of segments for product development

A
  1. evaluate individual segments
  2. does the segment have adequate size to reach financial targets
  3. can patients be easily identified and targeted
  4. can high volume users be targeted
  5. will the product meet unmet patient needs
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9
Q

what are the stages in product development which add up to target product profile

A
  1. identification of the drug substance
  2. identification and development of the drug product
  3. pre clinical production of the drug product
  4. pharmacological and toxicological profile including ADME
  5. drug product quality
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10
Q

what is target product profile

A

a prospective and dynamic summary of the quality characteristics of a drug product that ideally will be achieved to ensure that the desired quality, safety and efficacy of a drug product is realised
- forms the basis of design for the development of the product

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11
Q

what is included in a target product profile

A
  1. business plan
  2. drug discovery
  3. drug product development
  4. pre clinical investigations
  5. phase I clinical trial
  6. phase II clinical trial
  7. trial strategy
  8. IND/NDA applications
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12
Q

what does the business plan involve

A
  1. objective
  2. market potential including current availability and unmet patient needs
  3. financial implications
  4. risk assessment and mitigation
  5. target achievement
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13
Q

what is involved in drug discovery for a target product profile

A
  1. rationale for drug development
  2. synthesis or isolation
  3. purification and physicochemical characterisation
  4. efficacy establishment
  5. identification of lead compounds
  6. development of batch formula
  7. establishing GMP supply for product development
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14
Q

what is the aim of drug product development

A

to develop a quality product and its manufacturing process to consistently deliver the intended performance

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15
Q

what are the factors influencing pharmaceutical development

A
  1. increased scientific understanding to support design space
  2. quality built into design space
    3.establishing specifications and manufacturing controls
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16
Q

what is involved in drug product development

A
  1. description of dosage forms
  2. manufacturing process of the product
  3. components of the drug product
  4. packaging systems and their suitability
  5. continuous process verification
  6. QA/QC
  7. risk analysis
17
Q

what are the requirements of the drug substance in a drug product

A
  1. physicochemical and biological properties
  2. manufacturability
  3. acceptance criteria for drug substances
    - physical parameters
    - impurities
    - related substances
    - potential degradation products
    - process intermediates
18
Q

what are the requirements of excipients used in a drug product

A
  1. should be generally regarded as safe
  2. should be included in FDA inactive ingredient guidelines
  3. concentration and characteristics can influence product performance, manufacture, stability
  4. should not possess any quality by themselves
  5. doesn’t include antioxidants, preservatives
  6. compatibility of excipients with other excipients and drug substance should be established
  7. safety info should be established
19
Q

what is involved in formulation development for a target product profile

A
  1. summary of manufacture
  2. description of dosage form choice
    - based on route of administration, patient compliance and effectiveness
  3. highlight evolution of formulation development process
  4. cross reference to any comparator products
  5. development of batch formula
20
Q

what is involved in batch formula and specifications

A
  1. justified for the application
    - can be based on existing product
    - evolution of formulation development
  2. ease of manufacture
  3. special design features of the product should also be identified
    - tablet score line
    - overage
21
Q

what are overages not meant for

A

not meant for compensation for drug degradation over intended shelf life

22
Q

what should a batch formula contain in terms of overage

A
  1. amount of overage
  2. reason
  3. justification of amount
23
Q

what is involved in the method of manufacture

A
  1. initial methods developed
  2. finalisation of the procedure based on finalisation of batch formula
  3. justification of procedure
  4. usage and specifications of equipment
  5. validation of procedure
  6. determination of in process variables
  7. continuous process verification
  8. QA and QC of final product
24
Q

what should the target product profile contain in terms of manufacturing process

A
  1. significant differences between manufacturing process for
    - formulation development
    - pre clinical batch
    - clinical batch
  2. justification for variation should be based on safety, efficacy, bioavailability
  3. information should be clear and unambiguous
  4. critical stages for process verification
  5. process end points
  6. process robustness should be determined
  7. risk analysis and management
25
Q

what is involved in risk analysis and mitigation

A
  1. identify risks as early as possible and think of ways to mitigate the risks
26
Q

describe how to mitigate the risk of a product having an unacceptable toxicity profile

A
  • safety to patient
  • better to have backup formulation or API
27
Q

how to mitigate risk of adequate effect not being observed in patients

A

lab results don’t correlate with patient results
- strong possibility of clinical failure
- choose lab model closest matching to clinical scenario

28
Q

describe how to mitigate he risk of the product being physically or chemically unstable upon long term storage

A
  • main problem with formulation development
  • have a backup formulation
29
Q

describe how to mitigate the risk of the correct drug delivery profile not being attained

A
  • correct amount of API should reach site of action
  • suitable dose ranging studies in wider populations could reduce risk
  • increased dosage can increase risk of side effects
30
Q

describe how to mitigate the risk of the final formulation not being aesthetically or cosmetically acceptable to the patient or healthcare professional

A
  • include humectants in the formulation
  • have a backup formulation

PY366 Drug discovery (15 decks)

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