Product design strategies Flashcards
what are the regulatory controls that need to be put in place for drug product development
- good laboratory practice (GLP)- non clinical regulatory work
- good manufacturing practice (GMP)- preclinical and clinical manufacture of both API and drug product
- good clinical practice (GCP)
- quality assurance and quality control
- qualified person- legally responsible for audit and release of API/product into market for human use
what steps are needed before developing a new drug product
- understand the market environment
- develop therapies to see unmet medical and realised market needs
- start with the end in mind and develop a plan
- understand the financial implication
- factor in the risks
- build exit strategy
- create product plan
outline the strategic planning approach
- market mapping/prioritisation
- define success
- develop TPP
- manufacturing and formulation strategy
- clinical development strategy
- financial projections
- exit strategy
what is involved in understanding the market needs
- Market mapping
- patient prevelence
- patient diagnosis/undiagnosed patients
- patient category (high/low risk)
- current therapies in use
what are the targets for a new product
- efficacy
- ease of administration
- greater patient compliance
- well tolerated therapy, minimal side effects
what is the primary barrier to new drug products
- 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)
what is the unique value proposition for market segment
- identify important and different features and benefits compared to other products
- sustainable and should help in product trial and usage
- create TPP to highlight and drive product development and clinical testing to demonstrate benefits
what is involved in the prioritisation of segments for product development
- evaluate individual segments
- does the segment have adequate size to reach financial targets
- can patients be easily identified and targeted
- can high volume users be targeted
- will the product meet unmet patient needs
what are the stages in product development which add up to target product profile
- identification of the drug substance
- identification and development of the drug product
- pre clinical production of the drug product
- pharmacological and toxicological profile including ADME
- drug product quality
what is target product profile
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
what is included in a target product profile
- business plan
- drug discovery
- drug product development
- pre clinical investigations
- phase I clinical trial
- phase II clinical trial
- trial strategy
- IND/NDA applications
what does the business plan involve
- objective
- market potential including current availability and unmet patient needs
- financial implications
- risk assessment and mitigation
- target achievement
what is involved in drug discovery for a target product profile
- rationale for drug development
- synthesis or isolation
- purification and physicochemical characterisation
- efficacy establishment
- identification of lead compounds
- development of batch formula
- establishing GMP supply for product development
what is the aim of drug product development
to develop a quality product and its manufacturing process to consistently deliver the intended performance
what are the factors influencing pharmaceutical development
- increased scientific understanding to support design space
- quality built into design space
3.establishing specifications and manufacturing controls
what is involved in drug product development
- description of dosage forms
- manufacturing process of the product
- components of the drug product
- packaging systems and their suitability
- continuous process verification
- QA/QC
- risk analysis
what are the requirements of the drug substance in a drug product
- physicochemical and biological properties
- manufacturability
- acceptance criteria for drug substances
- physical parameters
- impurities
- related substances
- potential degradation products
- process intermediates
what are the requirements of excipients used in a drug product
- should be generally regarded as safe
- should be included in FDA inactive ingredient guidelines
- concentration and characteristics can influence product performance, manufacture, stability
- should not possess any quality by themselves
- doesn’t include antioxidants, preservatives
- compatibility of excipients with other excipients and drug substance should be established
- safety info should be established
what is involved in formulation development for a target product profile
- summary of manufacture
- description of dosage form choice
- based on route of administration, patient compliance and effectiveness - highlight evolution of formulation development process
- cross reference to any comparator products
- development of batch formula
what is involved in batch formula and specifications
- justified for the application
- can be based on existing product
- evolution of formulation development - ease of manufacture
- special design features of the product should also be identified
- tablet score line
- overage
what are overages not meant for
not meant for compensation for drug degradation over intended shelf life
what should a batch formula contain in terms of overage
- amount of overage
- reason
- justification of amount
what is involved in the method of manufacture
- initial methods developed
- finalisation of the procedure based on finalisation of batch formula
- justification of procedure
- usage and specifications of equipment
- validation of procedure
- determination of in process variables
- continuous process verification
- QA and QC of final product
what should the target product profile contain in terms of manufacturing process
- significant differences between manufacturing process for
- formulation development
- pre clinical batch
- clinical batch - justification for variation should be based on safety, efficacy, bioavailability
- information should be clear and unambiguous
- critical stages for process verification
- process end points
- process robustness should be determined
- risk analysis and management
what is involved in risk analysis and mitigation
- identify risks as early as possible and think of ways to mitigate the risks
describe how to mitigate the risk of a product having an unacceptable toxicity profile
- safety to patient
- better to have backup formulation or API
how to mitigate risk of adequate effect not being observed in patients
lab results don’t correlate with patient results
- strong possibility of clinical failure
- choose lab model closest matching to clinical scenario
describe how to mitigate he risk of the product being physically or chemically unstable upon long term storage
- main problem with formulation development
- have a backup formulation
describe how to mitigate the risk of the correct drug delivery profile not being attained
- 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
describe how to mitigate the risk of the final formulation not being aesthetically or cosmetically acceptable to the patient or healthcare professional
- include humectants in the formulation
- have a backup formulation
