Short answer

When assessing product quality or market risks, prioritize sampling methods that directly correlate with actual consumer usage and accessibility to obtain more representative data.

Field
Innovation & Markets
Source
medRxiv (2022)
Method
Exposure-based sampling and laboratory analysis (High Performance Liquid Chromatography and dissolution testing).
Sample
204 samples (88 amlodipine, 22 captopril, 21 furosemide, 21 glibenclamide, 52 simvastatin) comprising 83 different brands/products.
Evidence
Strong effect

A targeted sampling methodology, reflecting actual patient exposure, found that cardiovascular and diabetes medications in Malang District, Indonesia, met quality standards, suggesting a lower risk of substandard drugs than previously indicated by broader, less targeted studies. This innovation & markets research insight is drawn from a 2022 study published in medRxiv. Using Exposure-based sampling and laboratory analysis (high performance liquid chromatography and dissolution testing). with 204 samples (88 amlodipine, 22 captopril, 21 furosemide, 21 glibenclamide, 52 simvastatin) comprising 83 different brands/products., researchers explored how this design variable affects real-world outcomes. The key design takeaway: When assessing product quality or market risks, prioritize sampling methods that directly correlate with actual consumer usage and accessibility to obtain more representative data.

Study
Innovation & MarketsHigh ImpactStrong effect

Exposure-based sampling reveals low risk of substandard cardiovascular and diabetes medicines in Malang District

A targeted sampling methodology, reflecting actual patient exposure, found that cardiovascular and diabetes medications in Malang District, Indonesia, met quality standards, suggesting a lower risk of substandard drugs than previously indicated by broader, less targeted studies.

medRxiv · 2022

01

Key Findings

  • 01All 204 tested samples of cardiovascular and diabetes medicines met specifications for both active ingredient assay and dissolution.
  • 02None of the samples were suspected of being falsified.
  • 03The exposure-based sampling method suggested a very low risk of substandard medicines to patients in Malang District.
02

Application

Design takeaway

When assessing product quality or market risks, prioritize sampling methods that directly correlate with actual consumer usage and accessibility to obtain more representative data.

How to apply

When designing a market entry strategy or a quality control program for a new product, consider how to sample and test products in a way that reflects how consumers will actually encounter and use them.

Project actions

  • 01When planning your research, think about how your participants will actually interact with the product or system you are studying.
  • 02Consider if your sampling method truly represents the real-world use of the item you are investigating.
03

Method & Evidence

AimTo assess the quality of cardiovascular and diabetes medicines in Malang District, Indonesia, using a sampling method that reflects patient exposure.
MethodExposure-based sampling and laboratory analysis (High Performance Liquid Chromatography and dissolution testing).
ProcedureSamples of five key cardiovascular and diabetes medications (amlodipine, captopril, furosemide, glibenclamide, and simvastatin) were collected from public and private providers and pharmacies. The sampling frame was determined by dispensing volumes and price categories to reflect likely patient exposure. Active ingredient content and dissolution rates were tested against labelled specifications.
Sample204 samples (88 amlodipine, 22 captopril, 21 furosemide, 21 glibenclamide, 52 simvastatin) comprising 83 different brands/products.
ContextPharmaceutical market quality assessment in a specific district in Indonesia.

Variables

IVSampling methodology (exposure-based vs. other methods).
DVQuality of medicines (assay and dissolution test results).
CVType of medicine, manufacturing origin (all Indonesian), geographic location (Malang District).
04

Strengths & Limitations

Strengths

  • +Employed a novel and relevant sampling methodology (exposure-based).
  • +Conducted rigorous laboratory testing for quality assurance.

Limitations

The findings are specific to Malang District and may not be generalizable to other regions or countries. The study focused only on assay and dissolution, not on other potential quality defects or the efficacy of the medications.

Reliability & validity

Reliability is supported by the use of standardized laboratory tests (HPLC, dissolution). Validity is enhanced by the exposure-based sampling method, which aims to improve the ecological validity of the findings by reflecting real-world drug use.

Think critically

How might the economic and regulatory landscape of Malang District have influenced the quality of medicines, and to what extent could these findings be generalized to other regions with different market structures?

05

Design Principles

"Market risk assessment should be informed by actual consumer exposure patterns."

This research highlights the critical importance of employing exposure-based sampling in market research and quality control. Traditional sampling methods may overestimate risks by not accounting for actual product usage and patient access, leading to potentially misdirected regulatory efforts and market perceptions.

06

What This Means for Your Design

This study shows that if you test medicines based on how many people actually use them, you can get a better idea of whether they are good quality. In one area of Indonesia, the medicines tested were all good, meaning people were likely not at high risk from bad drugs.

How to use in your project

  • 1.Reference this study when discussing the importance of representative sampling in your design project's methodology section, particularly if your project involves assessing product quality or user behaviour in a specific market.
07

Add to My Project

08

Quick Cite

Paragraph starter

This research highlights the critical need for exposure-based sampling in quality assessment. By mirroring actual patient consumption patterns in Malang District, Indonesia, the study revealed that cardiovascular and diabetes medications met quality standards, contradicting broader concerns about substandard drugs in LMICs. This underscores the importance of tailoring sampling strategies to reflect real-world usage for accurate risk assessment and market understanding.

09

Source

medRxiv

A study of the quality of cardiovascular and diabetes medicines in Malang District, Indonesia, using exposure-based sampling

journal · 2022

View source

Questions About This Research

What does the research say about exposure-based sampling reveals low risk of substandard cardiovascular and diabetes medicines in malang district?
When assessing product quality or market risks, prioritize sampling methods that directly correlate with actual consumer usage and accessibility to obtain more representative data. Evidence: medRxiv (2022).
Why does "Exposure-based sampling reveals low risk of substandard cardiovascular and diabetes medicines in Malang District" matter for design?
This research highlights the critical importance of employing exposure-based sampling in market research and quality control. Traditional sampling methods may overestimate risks by not accounting for actual product usage and patient access, leading to potentially misdirected regulatory efforts and market perceptions.
How can designers apply this research?
When assessing product quality or market risks, prioritize sampling methods that directly correlate with actual consumer usage and accessibility to obtain more representative data.
What were the main findings?
All 204 tested samples of cardiovascular and diabetes medicines met specifications for both active ingredient assay and dissolution.. None of the samples were suspected of being falsified.. The exposure-based sampling method suggested a very low risk of substandard medicines to patients in Malang District.
What research method was used?
Exposure-based sampling and laboratory analysis (High Performance Liquid Chromatography and dissolution testing). with 204 samples (88 amlodipine, 22 captopril, 21 furosemide, 21 glibenclamide, 52 simvastatin) comprising 83 different brands/products..
How strong is the evidence?
Evidence strength is rated Strong effect, based on a 2022 journal from medRxiv.
What should I do differently in my next project?
When designing a market entry strategy or a quality control program for a new product, consider how to sample and test products in a way that reflects how consumers will actually encounter and use them.
What are the limitations?
The study was limited to a specific geographic region (Malang District) and a select group of cardiovascular and diabetes medications. It does not preclude the possibility of substandard medicines existing elsewhere or for other drug classes. The study did not investigate other potential quality issues beyond active ingredient content and dissolution.