Product and process development compliance in the Indian biopharmaceutical industry: Challenges and innovations
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Shivangi Uppal
Navjeevan Dadwal
Abstract
This study explored product and process development in the Indian biopharmaceutical industries, crucial in developing, manufacturing, and distributing biopharmaceutical products. Quality by Design (QbD) is a fundamental approach guiding product development, integrating scientific principles, and risk management throughout the lifecycle of biopharmaceutical products. Compliance, desired by regulatory bodies such as the Central Drugs Standard Control Organization (CDSCO), the U.S. Food and Drug Administration (FDA), the European Medicines Evaluation Agency (EMEA), and the International Organization for Standardization (ISO), is essential for market approval and global acceptance. This study examined the Indian biopharmaceutical industry’s process and product development standards, focusing on regulatory compliance, international collaborations, operational transparency, inspection practices, and challenges. The results indicated that most companies align with regulatory standards, emphasizing commitment to safety and efficacy in biopharmaceutical product development. International collaborations were highlighted as crucial for innovation and knowledge exchange but presented challenges in harmonizing diverse regulatory frameworks. Clear standard operating procedures (SOP) and routine inspections were important for ensuring product quality and safety, reflecting a commitment to high manufacturing standards. However, the study identified minor challenges, such as the economic feasibility of biopharmaceutical production, and frequently changing regulatory guidelines. Solutions proposed included fostering collaborations with research institutions and enhancing transparency in communication to address industry challenges effectively. The study also highlighted the high costs and regulatory challenges in developing new drugs, promoting collaboration with the biotechnology industry. Furthermore, the research findings align with the "Make in India" initiative, emphasizing transparency, collaboration, and innovation to promote domestic manufacturing capabilities and position India as a global biopharmaceutical manufacturing hub. The Indian biopharmaceutical industry firmly commits to regulatory compliance and manufacturing excellence.
How to Cite
Uppal, S., & Dadwal , N. Product and process development compliance in the Indian biopharmaceutical industry: Challenges and innovations. Environment Conservation Journal, 25(4). https://doi.org/10.36953/ECJ.28462883
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Keywords
CDSCO, FDA, Indian Biopharmaceutical Industry, Make In India, Product and process development, Quality By Design
References
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Alosert, H., Savery, J., Rheaume, J., Cheeks, M., Turner, R., Spencer, C., ... & Goldrick, S. (2022). Data integrity within the biopharmaceutical sector in the era of Industry 4.0. Biotechnology Journal, 17(6), 2100609.
Angeli, F. (2014). With the help of a foreign ally: biopharmaceutical innovation in India after TRIPS. Health Policy and Planning, 29(3), 280-291.
Ankrah, S., & Omar, A. T. (2015). Universities–industry collaboration: A systematic review. Scandinavian journal of management, 31(3), 387-408.
Avallone, H. L., Beatrice, M. G., & Sze, T. T. (1991). Inspection and Licensing of Manufacturing Facilities. Drug Biotechnology Regulation: Scientific Basis and Practices, 13, 315.
Avallone, H. L., Beatrice, M. G., & Sze, T. T. (1991). Inspection and Licensing of Manufacturing Facilities. Drug Biotechnology Regulation: Scientific Basis and Practices, 13, 315.
Avis, K. E., & Wu, V. L. (Eds.). (2020). Biotechnology and biopharmaceutical manufacturing, processing, and preservation. CRC Press.
Basu, S. B., Gupta, A. D., Ecks, S., Jeffery, P., Jeffery, R., Singh, N., & Subedi, M. S. (2007). GOOD MANUFACTURING PRACTICE IN THE PHARMACEUTICAL INDUSTRY.
Bayked, E. M., Kahissay, M. H., & Workneh, B. D. (2019). Assessment of inventory and store management practices of pharmaceuticals in public health centers and hospitals of Dessie Town, Ethiopia.
Bennett, L. M., & Gadlin, H. (2012). Collaboration and team science: from theory to practice.
Chhabra, M. (2021). Biological therapeutic modalities. In Translational biotechnology (pp. 137-164). Academic Press.
Chirmule, N., Bhat, S., & Mondal, S. (2021). Biopharmaceutical development in India: recommendations on collaboration and innovation to enable affordable healthcare. Drug Discovery and Drug Development: The Indian Narrative, 255-281.
Choudhry, N. K., Stelfox, H. T., & Detsky, A. S. (2002). Relationships between authors of clinical practice guidelines and the pharmaceutical industry. Jama, 287(5), 612-617.
DiMasi, J. A., & Grabowski, H. G. (2007). The cost of biopharmaceutical R&D: is biotech different?. Managerial and decision Economics, 28(4‐5), 469-479.
Downs, J. B., & Velamuri, V. (2016). Business model innovation opportunities for the biopharmaceutical industry: A systematic review. Journal of Commercial Biotechnology, 22(3).
Eder, J., & Herrling, P. L. (2016). Trends in modern drug discovery. New approaches to drug discovery, 3-22.
Elhassan, G. O., Khalid, B. E. S., Abd Alrouf, A. B., Akhtar, J., Khan, R., Khan, J., & Alfarouq, K. O. (2014). Good storage practice in pharmaceutical manufacturing plants in Khartoum State of Sudan. Indo Global Journal of Pharmaceutical Sciences, 4(2), 100-102.
George, B. (2017). A revolution in the making. Manipal Journal of Pharmaceutical Sciences, 3(1), 4-7.
Gonçalves, G. A. R., & Paiva, R. D. M. A. (2017). Gene therapy: advances, challenges and perspectives. Einstein (Sao Paulo), 15, 369-375.
Gupta, S. K., Nayak, R. P., Shivaranjani, R., & Vidyarthi, S. K. (2015). A questionnaire study on the knowledge, attitude, and the practice of pharmacovigilance among the healthcare professionals in a teaching hospital in South India. Perspectives in clinical research, 6(1), 45-52.
Hahn, J. (2009). Biopharmaceuticals-challenges and opportunities facing the drug-delivery industry. Touch Brief, 2009, 114-118.
Haider, R. (2023). Pharmaceutical and Biopharmaceuticals Industries: Revolutionizing Healthcare. Asian Journal of Natural Sciences, 2(2).
Hock, S. C., Kian, S. M., & Wah, C. L. (2020). Global challenges in the manufacture, regulation and international harmonization of GMP and quality standards for biopharmaceuticals. Generics and Biosimilars Initiative Journal, 9(2), 52-64.
Hyman, P. L., Hochman, M. E., Shaw, J. G., & Steinman, M. A. (2007). Attitudes of preclinical and clinical medical students toward interactions with the pharmaceutical industry. Academic Medicine, 82(1), 94-99.
Jadhav, N. V., Singh, N., Targhotra, M., & Chauhan, M. K. (2021). Impact of COVID-19 on Indian pharmaceutical industry and way forward. Infectious Disorders-Drug Targets (Formerly Current Drug Targets-Infectious Disorders), 21(4), 484-494.
Jameel, F., & Wolfrum, S. (2015). A QbD approach in the development and scale-up of mixing processes. Quality by Design for Biopharmaceutical Drug Product Development, 211-236.
Jarva, H., & Zeitler, T. (2023). Implications of the COVID-19 pandemic on internal auditing: a field study. Journal of Applied Accounting Research, 25(2), 355-370.
Jha, R., & Sharma, A. (2020). India’s pharmaceutical industry: Global supply chain and governance in the post-COVID-19 world. Available at SSRN 3622794.
Jiang, M., Severson, K. A., Love, J. C., Madden, H., Swann, P., Zang, L., & Braatz, R. D. (2017). Opportunities and challenges of real‐time release testing in biopharmaceutical manufacturing. Biotechnology and Bioengineering, 114(11), 2445-2456.
Kiriinya, A. E., Ngugi, P. K. N., Mwangangi, P., & Odhiambo, R. (2018). Influence of trust and transparency on performance of pharmaceutical firms in Kenya. European Journal of Business and Strategic Management, 3(8), 17-31.
Kneller, R. (2010). The importance of new companies for drug discovery: origins of a decade of new drugs. Nature reviews Drug discovery, 9(11), 867-882.
Lawrence, X. Y., & Woodcock, J. (2015). FDA pharmaceutical quality oversight. International journal of pharmaceutics, 491(1-2), 2-7.
Lee, J., Lee, H. S., Shin, H., & Krishnan, V. (2021). Alleviating drug shortages: The role of mandated reporting induced operational transparency. Management Science, 67(4), 2326-2339.
Lim, S. Y., & Suh, M. (2015). Product and process innovation in the development cycle of biopharmaceuticals. Journal of Pharmaceutical Innovation, 10, 156-165.
Lubiniecki, A. S. (1997). Potential influence of international harmonization of pharmaceutical regulations on biopharmaceutical development. Current opinion in biotechnology, 8(3), 350-356.
Milá Cáceres, L. (2010). Quality Risk Management Application Review in Pharmaceutical and Biopharmaceutical Industries. Bioprocessing Journal, 9(1).
Moorkens, E., Meuwissen, N., Huys, I., Declerck, P., Vulto, A. G., & Simoens, S. (2017). The market of biopharmaceutical medicines: a snapshot of a diverse industrial landscape. Frontiers in pharmacology, 8, 314.
Narhi, L. O., Bou-Assaf, G. M., Gonzalez, K., Mazaheri, M., Messick, S. K., & Telikepalli, S. N. (2021, May). Filling the pharmacopeial gaps of visual inspection: toward standardization and consistency of visible particle testing. In Pharmacopeial Forum (Vol. 47, No. 3).
Nayak, A. K., Ahmed, S. A., Beg, S., Tabish, M., & Hasnain, M. S. (2019). Application of quality by design for the development of biopharmaceuticals. In Pharmaceutical quality by design (pp. 399-411). Academic Press.
Nayak, A. K., Ahmed, S. A., Beg, S., Tabish, M., & Hasnain, M. S. (2019). Application of quality by design for the development of biopharmaceuticals. In Pharmaceutical quality by design (pp. 399-411). Academic Press.
Permanand, G., Mossialos, E., & McKee, M. (2006). Regulating medicines in Europe: the European Medicines Agency, marketing authorisation, transparency and pharmacovigilance. Clinical medicine, 6(1), 87-90.
Powell, W. W. (1996). Inter-organizational collaboration in the biotechnology industry. Journal of Institutional and Theoretical Economics (JITE)/Zeitschrift für die gesamte Staatswissenschaft, 197-215.
Priyadarshan, C., & Pushkarna, M. (2023). Covid-19: An Analytical Study on Licensing and Vaccine IPR in India: With Reference to the Existing Pharmaceutical Industry and Its Evolution Post Pandemic. Issue 4 Int'l J.L. Mgmt. & Human., 6, 1232.
Rastogi, S., & Jadaun, G. P. S. (2024). 1 Regulatory of Quality Control Aspects. Quality Control and Regulatory Aspects for Biologicals: Regulations and Best Practices, 1.
Rathore, A. S., Li, Y., Chhabra, H., & Lohiya, A. (2023). FDA warning letters: a retrospective analysis of letters issued to pharmaceutical companies from 2010–2020. Journal of Pharmaceutical Innovation, 18(2), 665-674.
Reichert, J. M. (2006). Trends in U.S. approvals: new biopharmaceuticals and vaccines. Trends in biotechnology, 24(7), 293-298.
Reichert, J. M., & Healy, E. M. (2001). Biopharmaceuticals approved in the E.U. 1995–1999: a European Union–United States comparison. European journal of pharmaceutics and biopharmaceutics, 51(1), 1-7.
Rittiner, F. (2015). Striving for Product Development Excellence-Lessons Learned from the Implementation of Lean Management (Doctoral dissertation, ETH Zurich).
Sahoo, N., Choudhury, K., & Manchikanti, P. (2009). Manufacturing of biodrugs: need for harmonization in regulatory standards. BioDrugs, 23, 217-229.
Sayed, N., Allawadhi, P., Khurana, A., Singh, V., Navik, U., Pasumarthi, S. K., ... & Bharani, K. K. (2022). Gene therapy: Comprehensive overview and therapeutic applications. Life sciences, 294, 120375.
Sekhon, B. S. (2010). Biopharmaceuticals: an overview. Thai Journal of Pharmaceutical Sciences, 34(1).
Singh, P., Shukla, S., & Misra, G. (2024). Good Manufacturing Practices in Quality Control. In Quality Control and Regulatory Aspects for Biologicals (pp. 100-118). CRC Press.
Stehlik-Barry, K., & Babinec, A. J. (2017). Data analysis with IBM SPSS statistics. Packt Publishing Ltd.
Taylor, D. (2015). The pharmaceutical industry and the future of drug development.
Terblanche, N. S. (2008). New pharmaceutical product development: Barriers to overcome and opportunities to exploit. Journal of Commercial Biotechnology, 14, 201-212.
Tsang, S., Royse, C. F., & Terkawi, A. S. (2017). Guidelines for developing, translating, and validating a questionnaire in perioperative and pain medicine. Saudi journal of anaesthesia, 11(Suppl 1), S80-S89.
Walsh, G. (1999). The EMEA and regulatory control of (bio) pharmaceuticals within the European Union. Biopharmaceuticals, an Industrial Perspective, 289-310.
Willey, T. (2017). "Biopharmaceuticals: Trends and Challenges in Production and Regulation." International Journal of Transcontinental Discoveries, ISSN: 3006-628X 4, no. 1: 14-20.
Wise, J., de Barron, A. G., Splendiani, A., Balali-Mood, B., Vasant, D., Little, E., ... & Hedley, V. (2019). Implementation and relevance of FAIR data principles in biopharmaceutical R&D. Drug discovery today, 24(4), 933-938.
Abed, M., Al Omari, S., Mourad, R., & Al Faraj, A. (2022). Cross-sectional study of the knowledge, perception and attitude of first-year university students in Iraq towards SARS-CoV-2 Omicron variant and COVID-19 vaccines. BMJ open, 12(11), e064301.
Alosert, H., Savery, J., Rheaume, J., Cheeks, M., Turner, R., Spencer, C., ... & Goldrick, S. (2022). Data integrity within the biopharmaceutical sector in the era of Industry 4.0. Biotechnology Journal, 17(6), 2100609.
Angeli, F. (2014). With the help of a foreign ally: biopharmaceutical innovation in India after TRIPS. Health Policy and Planning, 29(3), 280-291.
Ankrah, S., & Omar, A. T. (2015). Universities–industry collaboration: A systematic review. Scandinavian journal of management, 31(3), 387-408.
Avallone, H. L., Beatrice, M. G., & Sze, T. T. (1991). Inspection and Licensing of Manufacturing Facilities. Drug Biotechnology Regulation: Scientific Basis and Practices, 13, 315.
Avallone, H. L., Beatrice, M. G., & Sze, T. T. (1991). Inspection and Licensing of Manufacturing Facilities. Drug Biotechnology Regulation: Scientific Basis and Practices, 13, 315.
Avis, K. E., & Wu, V. L. (Eds.). (2020). Biotechnology and biopharmaceutical manufacturing, processing, and preservation. CRC Press.
Basu, S. B., Gupta, A. D., Ecks, S., Jeffery, P., Jeffery, R., Singh, N., & Subedi, M. S. (2007). GOOD MANUFACTURING PRACTICE IN THE PHARMACEUTICAL INDUSTRY.
Bayked, E. M., Kahissay, M. H., & Workneh, B. D. (2019). Assessment of inventory and store management practices of pharmaceuticals in public health centers and hospitals of Dessie Town, Ethiopia.
Bennett, L. M., & Gadlin, H. (2012). Collaboration and team science: from theory to practice.
Chhabra, M. (2021). Biological therapeutic modalities. In Translational biotechnology (pp. 137-164). Academic Press.
Chirmule, N., Bhat, S., & Mondal, S. (2021). Biopharmaceutical development in India: recommendations on collaboration and innovation to enable affordable healthcare. Drug Discovery and Drug Development: The Indian Narrative, 255-281.
Choudhry, N. K., Stelfox, H. T., & Detsky, A. S. (2002). Relationships between authors of clinical practice guidelines and the pharmaceutical industry. Jama, 287(5), 612-617.
DiMasi, J. A., & Grabowski, H. G. (2007). The cost of biopharmaceutical R&D: is biotech different?. Managerial and decision Economics, 28(4‐5), 469-479.
Downs, J. B., & Velamuri, V. (2016). Business model innovation opportunities for the biopharmaceutical industry: A systematic review. Journal of Commercial Biotechnology, 22(3).
Eder, J., & Herrling, P. L. (2016). Trends in modern drug discovery. New approaches to drug discovery, 3-22.
Elhassan, G. O., Khalid, B. E. S., Abd Alrouf, A. B., Akhtar, J., Khan, R., Khan, J., & Alfarouq, K. O. (2014). Good storage practice in pharmaceutical manufacturing plants in Khartoum State of Sudan. Indo Global Journal of Pharmaceutical Sciences, 4(2), 100-102.
George, B. (2017). A revolution in the making. Manipal Journal of Pharmaceutical Sciences, 3(1), 4-7.
Gonçalves, G. A. R., & Paiva, R. D. M. A. (2017). Gene therapy: advances, challenges and perspectives. Einstein (Sao Paulo), 15, 369-375.
Gupta, S. K., Nayak, R. P., Shivaranjani, R., & Vidyarthi, S. K. (2015). A questionnaire study on the knowledge, attitude, and the practice of pharmacovigilance among the healthcare professionals in a teaching hospital in South India. Perspectives in clinical research, 6(1), 45-52.
Hahn, J. (2009). Biopharmaceuticals-challenges and opportunities facing the drug-delivery industry. Touch Brief, 2009, 114-118.
Haider, R. (2023). Pharmaceutical and Biopharmaceuticals Industries: Revolutionizing Healthcare. Asian Journal of Natural Sciences, 2(2).
Hock, S. C., Kian, S. M., & Wah, C. L. (2020). Global challenges in the manufacture, regulation and international harmonization of GMP and quality standards for biopharmaceuticals. Generics and Biosimilars Initiative Journal, 9(2), 52-64.
Hyman, P. L., Hochman, M. E., Shaw, J. G., & Steinman, M. A. (2007). Attitudes of preclinical and clinical medical students toward interactions with the pharmaceutical industry. Academic Medicine, 82(1), 94-99.
Jadhav, N. V., Singh, N., Targhotra, M., & Chauhan, M. K. (2021). Impact of COVID-19 on Indian pharmaceutical industry and way forward. Infectious Disorders-Drug Targets (Formerly Current Drug Targets-Infectious Disorders), 21(4), 484-494.
Jameel, F., & Wolfrum, S. (2015). A QbD approach in the development and scale-up of mixing processes. Quality by Design for Biopharmaceutical Drug Product Development, 211-236.
Jarva, H., & Zeitler, T. (2023). Implications of the COVID-19 pandemic on internal auditing: a field study. Journal of Applied Accounting Research, 25(2), 355-370.
Jha, R., & Sharma, A. (2020). India’s pharmaceutical industry: Global supply chain and governance in the post-COVID-19 world. Available at SSRN 3622794.
Jiang, M., Severson, K. A., Love, J. C., Madden, H., Swann, P., Zang, L., & Braatz, R. D. (2017). Opportunities and challenges of real‐time release testing in biopharmaceutical manufacturing. Biotechnology and Bioengineering, 114(11), 2445-2456.
Kiriinya, A. E., Ngugi, P. K. N., Mwangangi, P., & Odhiambo, R. (2018). Influence of trust and transparency on performance of pharmaceutical firms in Kenya. European Journal of Business and Strategic Management, 3(8), 17-31.
Kneller, R. (2010). The importance of new companies for drug discovery: origins of a decade of new drugs. Nature reviews Drug discovery, 9(11), 867-882.
Lawrence, X. Y., & Woodcock, J. (2015). FDA pharmaceutical quality oversight. International journal of pharmaceutics, 491(1-2), 2-7.
Lee, J., Lee, H. S., Shin, H., & Krishnan, V. (2021). Alleviating drug shortages: The role of mandated reporting induced operational transparency. Management Science, 67(4), 2326-2339.
Lim, S. Y., & Suh, M. (2015). Product and process innovation in the development cycle of biopharmaceuticals. Journal of Pharmaceutical Innovation, 10, 156-165.
Lubiniecki, A. S. (1997). Potential influence of international harmonization of pharmaceutical regulations on biopharmaceutical development. Current opinion in biotechnology, 8(3), 350-356.
Milá Cáceres, L. (2010). Quality Risk Management Application Review in Pharmaceutical and Biopharmaceutical Industries. Bioprocessing Journal, 9(1).
Moorkens, E., Meuwissen, N., Huys, I., Declerck, P., Vulto, A. G., & Simoens, S. (2017). The market of biopharmaceutical medicines: a snapshot of a diverse industrial landscape. Frontiers in pharmacology, 8, 314.
Narhi, L. O., Bou-Assaf, G. M., Gonzalez, K., Mazaheri, M., Messick, S. K., & Telikepalli, S. N. (2021, May). Filling the pharmacopeial gaps of visual inspection: toward standardization and consistency of visible particle testing. In Pharmacopeial Forum (Vol. 47, No. 3).
Nayak, A. K., Ahmed, S. A., Beg, S., Tabish, M., & Hasnain, M. S. (2019). Application of quality by design for the development of biopharmaceuticals. In Pharmaceutical quality by design (pp. 399-411). Academic Press.
Nayak, A. K., Ahmed, S. A., Beg, S., Tabish, M., & Hasnain, M. S. (2019). Application of quality by design for the development of biopharmaceuticals. In Pharmaceutical quality by design (pp. 399-411). Academic Press.
Permanand, G., Mossialos, E., & McKee, M. (2006). Regulating medicines in Europe: the European Medicines Agency, marketing authorisation, transparency and pharmacovigilance. Clinical medicine, 6(1), 87-90.
Powell, W. W. (1996). Inter-organizational collaboration in the biotechnology industry. Journal of Institutional and Theoretical Economics (JITE)/Zeitschrift für die gesamte Staatswissenschaft, 197-215.
Priyadarshan, C., & Pushkarna, M. (2023). Covid-19: An Analytical Study on Licensing and Vaccine IPR in India: With Reference to the Existing Pharmaceutical Industry and Its Evolution Post Pandemic. Issue 4 Int'l J.L. Mgmt. & Human., 6, 1232.
Rastogi, S., & Jadaun, G. P. S. (2024). 1 Regulatory of Quality Control Aspects. Quality Control and Regulatory Aspects for Biologicals: Regulations and Best Practices, 1.
Rathore, A. S., Li, Y., Chhabra, H., & Lohiya, A. (2023). FDA warning letters: a retrospective analysis of letters issued to pharmaceutical companies from 2010–2020. Journal of Pharmaceutical Innovation, 18(2), 665-674.
Reichert, J. M. (2006). Trends in U.S. approvals: new biopharmaceuticals and vaccines. Trends in biotechnology, 24(7), 293-298.
Reichert, J. M., & Healy, E. M. (2001). Biopharmaceuticals approved in the E.U. 1995–1999: a European Union–United States comparison. European journal of pharmaceutics and biopharmaceutics, 51(1), 1-7.
Rittiner, F. (2015). Striving for Product Development Excellence-Lessons Learned from the Implementation of Lean Management (Doctoral dissertation, ETH Zurich).
Sahoo, N., Choudhury, K., & Manchikanti, P. (2009). Manufacturing of biodrugs: need for harmonization in regulatory standards. BioDrugs, 23, 217-229.
Sayed, N., Allawadhi, P., Khurana, A., Singh, V., Navik, U., Pasumarthi, S. K., ... & Bharani, K. K. (2022). Gene therapy: Comprehensive overview and therapeutic applications. Life sciences, 294, 120375.
Sekhon, B. S. (2010). Biopharmaceuticals: an overview. Thai Journal of Pharmaceutical Sciences, 34(1).
Singh, P., Shukla, S., & Misra, G. (2024). Good Manufacturing Practices in Quality Control. In Quality Control and Regulatory Aspects for Biologicals (pp. 100-118). CRC Press.
Stehlik-Barry, K., & Babinec, A. J. (2017). Data analysis with IBM SPSS statistics. Packt Publishing Ltd.
Taylor, D. (2015). The pharmaceutical industry and the future of drug development.
Terblanche, N. S. (2008). New pharmaceutical product development: Barriers to overcome and opportunities to exploit. Journal of Commercial Biotechnology, 14, 201-212.
Tsang, S., Royse, C. F., & Terkawi, A. S. (2017). Guidelines for developing, translating, and validating a questionnaire in perioperative and pain medicine. Saudi journal of anaesthesia, 11(Suppl 1), S80-S89.
Walsh, G. (1999). The EMEA and regulatory control of (bio) pharmaceuticals within the European Union. Biopharmaceuticals, an Industrial Perspective, 289-310.
Willey, T. (2017). "Biopharmaceuticals: Trends and Challenges in Production and Regulation." International Journal of Transcontinental Discoveries, ISSN: 3006-628X 4, no. 1: 14-20.
Wise, J., de Barron, A. G., Splendiani, A., Balali-Mood, B., Vasant, D., Little, E., ... & Hedley, V. (2019). Implementation and relevance of FAIR data principles in biopharmaceutical R&D. Drug discovery today, 24(4), 933-938.
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