Discovery and Basic Research
Abhisheak Sharma, PhD
Assistant Professor and Assistant Director
University of Florida
Gainesville, Florida
Chaitanya Koduri, MTech (he/him/his)
Director
US Pharmacopeia
Rockville, Maryland
Analytical testing is integral to testing the drug product and access to proper analytical testing is essential for safeguarding a safe and effective drug product. Analytical testing services can improve access to healthcare especially where healthcare infrastructure is weak and access to quality and timely medical care is a challenge. Challenges include the absence of essential infrastructure, laboratory supplies, basic equipment, skilled personnel, supply chain management, and equipment maintenance; inadequate quality management systems; and no government standards for laboratory testing. Improving the accessibility and efficiency of analytical testing, particularly in resource-limited settings, would improve healthcare outcomes. This presentation will provide overview of the barriers and challenges to proper analytical testing in low- and middle- income countries (LMICs). impact on LMIC healthcare outcomes and factors contributing to the accessibility of analytical testing in LMICs. Supply chain and quality systems management, geographical location, health infrastructure, and an enabling policy framework will be discussed.