Achouri, I.E., Rhoden, A., Hudon, S., Gosselin, R., Simard, J.-S. and Abatzoglou, N. (2021). Non-invasive detection technologies of solid foreign matter and their applications to lyophilized pharmaceutical products: A review. Talanta, 224, p.121885.

Baradez, M.-O., Biziato, D., Hassan, E. and Marshall, D. (2018). Application of Raman Spectroscopy and Univariate Modelling As a Process Analytical Technology for Cell Therapy Bioprocessing. Frontiers in Medicine, 5.

Berridge, J.C. (2009). PQLI ®: Current Status and Future Plans. Journal of Pharmaceutical Innovation, 4(1), pp.1-3.

Bolo, M. and Vugigi, S. (2016). Incentvising African Pharmaceutical Manufacturing: Policies for sustaining the take-of. The Scinnovent Centre Technical briefing note no. 1. Nairobi, Kenya: The Scinnovent Centre.

Brearley, A.M. and Foulk, S.J. (2010). Near-Infrared Spectroscopy (NIR) as a PAT Tool in the Chemical Industry: Added Value and Implementation Challenges. Process Analytical Technology, pp.493-520.

Bryman, A. & Bell, E. (2007). Business Research Methods. 2nd edition, New York. Oxford: University Press Inc.

Burgess, T.F. (2001). Information System Services: Guide to the Design of Questionnaires. University of Leeds.

Burggraeve, A., Van Den Kerkhof, T., Hellings, M., Remon, J.P., Vervaet, C. and De Beer, T. (2010). Evaluation of in-line spatial filter velocimetry as PAT monitoring tool for particle growth during fluid bed granulation. European Journal of Pharmaceutics and Biopharmaceutics, 76(1), pp.138-146.

Carifio J. and Perla R. J. (2007). Ten common misunderstandings, misconceptions, persistent myths and urban legends about Likert scales and Likert response formats and their antidotes. Journal of Social Sciences. 3(3):106-116.

Challa, S. and Potumarthi, R. (2012). Chemometrics-Based Process Analytical Technology (PAT) Tools: Applications and Adaptation in Pharmaceutical and Biopharmaceutical Industries. Applied Biochemistry and Biotechnology, 169(1), pp.66-76.

Chiejina, A. (2014). Nigeria's Pharma imports to hit $789m by 2018. [online] Businessday NG. Available at: https://businessday.ng/science/article/nigerias pharma-imports-to-hit-789m-by-2018/ [Accessed May 2021].

Cogdill, R.P., Anderson, C.A., Delgado-Lopez, M., Molseed, D., Chisholm, R., Bolton, R., Herkert, T., Afnán, A.M. and Drennen, J.K. (2005). Process analytical technology case study part I: Feasibility studies for quantitative near infrared method development. AAPS PharmSciTech, 6(2), pp.E262-E272.

Cohen, L., Manion, L., & Morrison, K. (2007). Research Methods in Education (6th ed.). London and New York, NY: Routledge Falmer

Creswell, J. W. (2003). Research design: Qualitative, quantitative, and mixed method approaches (2nd ed.). London: Sage Publications.

Creswell, J. W. (2013). Research design: Qualitative, quantitative, and mixed method approaches.

Dave, R.H., Wu, S.H. and Contractor, L.D. (2011). To determine the end point of wet granulation by measuring powder energies and thermal properties. Drug Development and Industrial Pharmacy, 38(4), pp.439-446.

Doherty, S.J. and Kettler, C.N. (2005). On-Line Applications in the Pharmaceutical Industry. Process Analytical Technology, pp.329-361.

Ekeigwe, A.A. (2019). Drug manufacturing and access to medicines: the West African story. A literature review of challenges and proposed remediation. AAPS Open, 5(1).

FDA (2004). Guidance for Industry PAT — a Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. Silver Spring: Food and Drug Administration.

FDA (2009). FDA Guidance for Industry: Q8(R2) Pharmaceutical Development Revision 2. Silver Spring: Food and Drug Administration.

Federal Ministry of Health (2003). National Drug Policy. [online] . Available at: https://www.health.gov.ng/doc/DrugPolicy.pdf [Accessed Apr. 2021].

Fisher, A.C., Kamga, M.-H., Agarabi, C., Brorson, K., Lee, S.L. and Yoon, S. (2019). The Current Scientific and Regulatory Landscape in Advancing Integrated Continuous Biopharmaceutical Manufacturing. Trends in Biotechnology, [online] 37(3), pp.253-267. Available at: https://www.sciencedirect.com/science/article/pii/S0167779918302488.

Garson, G.D. (2012). Structural equation modelling. Raleigh, NC: statistical associates publishers.

Gibbs, G. (2007) Analysing Qualitative Data. SAGE Publications Ltd., New York, USA

Gupta, Y., O'Brien, T. and Ruiyao Gao (2013). Detection and Characterization of Acoustic Signals from a Granulation Process. 24th IET Irish Signals and Systems Conference (ISSC 2013).

Hickey, A.J. and Smyth, H.D.C. (2020). Pharmaco-complexity. AAPS Introductions in the Pharmaceutical Sciences. Cham: Springer International Publishing.

Ikoni Ogaji, J. and Alawode, A.O. (2014). Capacity Utilization in Pharmaceutical Industry in Nigeria. Pharmaceutical Regulatory Affairs: Open Access, 3(2).

Joshi A., Kale S., Chandel S. & Pal, D. (2015). Likert Scale: Explored and Explained. British Journal of Applied Science & Technology. 7. 396-403. 10.9734/BJAST/2015/14975.

Karmann, S., Follonier, S., Egger, D., Hebel, D., Panke, S. and Zinn, M. (2017). Tailor‐madePATplatform for safe syngas fermentations in batch, fed‐batch and chemostat mode withRhodospirillum rubrum. Microbial Biotechnology, 10(6), pp.1365-1375.

Kaynak, H. (2003). The relationship between total quality management practices and their effects on firm performance. Journal of Operations Management, [online] 21(4), pp.405-435. Available at: https://www.sciencedirect.com/science/article/pii/S0272696303000044.

Kessler, R.W. and Kessler, W. (2020). Best Practice and Performance of Hardware in Process Analytical Technology (PAT). Comprehensive Chemometrics, pp.237- 274.

Lawal, I.O. (2009). Library and Information Science Research in the 21st Century : a Guide for Practicing Librarians and Students. Oxford: Chandos.

Leech, N., Barret, K. and Morgan, G.A. (2004). SPSS for Intermediate Statistics Use and Interpretation, Second Edition. Routledge Academic.

Lobsy J. and Wetmore A. (2014). CDC Coffee Break: Using Likert Scales in Evaluation Survey Work [Internet]; Cdc.gov. Retrieved:www.cdc.gov/dhdsp/pubs/docs/CB_February_14_2021.pdf

Low, D. and Chrisman, R. (2012). conclusions, Current status, and Future Vision of Process Analytical Technology in Biologics. In: C. Undey, D. Low, J.C. Menezes and M. Koch, eds., PAT Applied in Biopharmaceutical Process Development and Manufacturing : an Enabling Tool for quality-by-design. Boca Raton, Fl: Crc Press.

Lundsberg-Nielsen, L., Schlindwein, W.S. and Berghaus, A. (2018). Process Analytical Technology (PAT). Pharmaceutical Quality by Design, pp.227-255.

Magnello, M.E. (2006) Karl Pearson and the origin of modern statistics: An elastician becomes a statistician, Rutherford J, Vol. 1. Available online at: http://rutherfordjournal.org

Malhotra N. K. (2006). Questionnaire Design and Scale Development. In: Grover R, Vriens M, editors. The Handbook of Marketing Research. California: Sage Publications, Inc.

Mante, J., Gangadharan, N., Sewell, D.J., Turner, R., Field, R., Oliver, S.G., Slater, N. and Dikicioglu, D. (2019). A heuristic approach to handling missing data in biologics manufacturing databases. Bioprocess and Biosystems Engineering, 42(4), pp.657-663.

Marshall, C., & Rossman, G. B. (1999). Designing qualitative research (3rd ed.). Sage Publications, Inc.

Mgbakor M. N., Uzendu P. O. and Onicha A. P. (2014). Economic Analysis of Bread Production with High Quality Cassava Flour in Ndokwa West Local Government Area of Delta State, Nigeria. Journal of Agriculture and Veterinary Science. Volume 7, Issue 8 Ver. I.

Mittal, P., Vardhan, H., Ajmal, G., Bonde, G.V., Kapoor, R., Mittal, A. and Mishra, B. (2019). Genistein-Loaded Nanostructured Lipid Carriers for Intravenous Administration: A Quality by Design Based Approach. International Research Journal Of Pharmacy, 10(1), pp.119-134.

Momeni, A., Pincus, M. and Libien, J. (2018). Introduction to Statistical Methods in Pathology. Cham: Springer International Publishing.

Mugenda, A. and Mugenda, O. (2013). Research methods: Quantitative and qualitative approaches. Nairobi: ACTS Press

NAFDAC (2017). NAFDAC Mandate - NAFDAC. [online] Nafdac.gov.ng. Available at: https://www.nafdac.gov.ng/about-nafdac/nafdac-organisation/nafdac functions/#:~:text=The%20act%20mandates%20the%20Agency,officially%20e stablished%20in%20October%201992. [Accessed Apr. 2021].

Nagy, Z.K., Fujiwara, M. and Braatz, R.D. (2019). Monitoring and Advanced Control of Crystallization Processes. Handbook of Industrial Crystallization, pp.313- 345.

Newing, H. (2011). Conducting research in conservation: Social science methods and practice. New York: Routledge

Ogada, T. (2019). Building a Competitive and Socially Inclusive Local Pharmaceutical Manufacturing in West Africa through Enhancing Research, Innovation and Intellectual Property. African Center for Technology Studies.

Okafor, U.G., Ibrahim Jatau Abubakar, Olukemi Alabi and Elijah Na Mohammed (2021). Assessment of awareness and satisfaction of online renewal of practising license among pharmacists in Nigeria. [online] ResearchGate. Available at: https://www.researchgate.net/publication/348949784_Assessment_of_awarenes s_and_satisfaction_of_online_renewal_of_practising_license_among_pharmacis ts_in_Nigeria [Accessed 17 Apr. 2021].

Ombrosi, N., Casprini, E. and Piccaluga, A. (2019). Designing and managing co innovation: the case of Loccioni and Pfizer. European Journal of Innovation Management, 22(4), pp.600-616.

Ostergaard, I., de Diego, H.L., Qu, H. and Nagy, Z.K. (2020). Risk-Based Operation of a Continuous Mixed-Suspension-Mixed-Product-Removal Antisolvent Crystallization Process for Polymorphic Control. Organic Process Research & Development, 24(12), pp.2840-2852.

Pazhayattil, A.B., Sayeed-Desta, N., Fredro-Kumbaradzi, E. and Collins, J. (2018). Solid Oral Dose Process Validation the Basics, Volume 1. Cham Springer International Publishing.

Peterson, K. (2014). On the monopoly: Speculation, pharmaceutical markets, and intellectual property law in Nigeria. American Ethnologist, 41(1), pp.128-142.

Rathbone, M.J., Hadgraft, J. and Roberts, M.S. (2003). Modified-release drug delivery technology. New York: Marcel Dekker.

Rathore, A.S. (2011). Follow-On Protein Products. Comprehensive Biotechnology, pp.521-529.

Richard, J. and Tweedie (2015). Process Analytical Instrumentation, the Challenges for In-situ Characterization of Complex Particulate Materials. Procedia Engineering, 102, pp.1714-1725.

Rodrigues, M., Baptista, B., Lopes, J.A. and Sarraguça, M.C. (2018). Pharmaceutical cocrystallization techniques. Advances and challenges. International Journal of Pharmaceutics, [online] 547(1), pp.404-420. Available at: https://www.sciencedirect.com/science/article/pii/S0378517318304216?casa_to ken=8I4eCcJ49pQAAAAA:bkuI1hELYoZ5Fh38roSjuvwC046KGDky6rYso0f QsUF9rZo36qzsOTyDNun7Tcman8xBRJNeQg [Accessed 30 Nov. 2020].

Salako, L.A. (1991). Drug supply in Nigeria. Journal of Clinical Epidemiology, 45, pp.15-19.

Salman Ben Zayed, Abdullah Bin Gani, Hesham Fathy Gadelrab and Mohd Khalit Bin Othman (2021). Operational management in emergency healthcare. Cham, Switzerland: Springer.

Sayin, R., Martinez-Marcos, L., Osorio, J.G., Cruise, P., Jones, I., Halbert, G.W., Lamprou, D.A. and Litster, J.D. (2015). Investigation of an 11 mm diameter twin screw granulator: Screw element performance and in-line monitoring via image analysis. International Journal of Pharmaceutics, 496(1), pp.24-32.

Simon, L.L., Pataki, H., Marosi, G., Meemken, F., Hungerbühler, K., Baiker, A., Tummala, S., Glennon, B., Kuentz, M., Steele, G., Kramer, H.J.M., Rydzak, J.W., Chen, Z., Morris, J., Kjell, F., Singh, R., Gani, R., Gernaey, K.V., Louhi Kultanen, M. and O'Reilly, J. (2015). Assessment of Recent Process Analytical Technology (PAT) Trends: A Multiauthor Review. Organic Process Research & Development, 19(1), pp.3-62.

Siyanbola, W.O., Oladipo, O.G., Oyewale, A.A., Famurewa, A.J. and Ogundari, I.O. (2012). Academia-Industry Interactions in Nigeria Pharmaceutical Innovation System. Procedia - Social and Behavioral Sciences, [online] 52, pp.279-289. Available at: https://www.sciencedirect.com/science/article/pii/S1877042812039201.

Snee, R.D. (2016). Quality by Design: Building Quality into Products and Processes. Nonclinical Statistics for Pharmaceutical and Biotechnology Industries, pp.461- 499.

Streefland, M., Martens, D.E., Beuvery, E.C. and Wijffels, R.H. (2013). Process analytical technology (PAT) tools for the cultivation step in biopharmaceutical production. Engineering in Life Sciences, 13(3), pp.212-223.

Szilagyi, B., Eren, A., Quon, J.L., Papageorgiou, C.D. and Nagy, Z.K. (2020). Application of Model-Free and Model-Based Quality-by-Control (QbC) for the Efficient Design of Pharmaceutical Crystallization Processes. Crystal Growth & Design, 20(6), pp.3979-3996.

Tripathi, N.K. and Shrivastava, A. (2018). Scale up of biopharmaceuticals production. Nanoscale Fabrication, Optimization, Scale-Up and Biological Aspects of Pharmaceutical Nanotechnology, pp.133-172.

Tsang K. K. (2012). The use of midpoint on Likert scale: The implications for educational research. Hong Kong Teachers Centre Journal.

Ugbam, O.C. and Okoro, E.A. (2017). A Strategic Study of the Nigerian Pharmaceutical Sector: Organizational Leadership, Market-share, and Competitive Performance. International Journal of Business, Humanities and Technology, 7(1).

Undey, C. (2012). PAT applied in biopharmaceutical process development and manufacturing : an enabling tool for quality-by-design. Boca Raton, Fl: Crc Press.

Vanhoorne, V. and Vervaet, C. (2020). Recent Progress in Continuous Manufacturing of Oral Solid Dosage Forms. International Journal of Pharmaceutics, 579, p.119194.

WHO (2014). WHO prequalification: Building quality-assured Manufacturing Capacity in Nigeria. WHO Drug Information, [online] 28(4), pp.425-430. Available at: https://apps.who.int/iris/handle/10665/331090 [Accessed 17 Apr. 2021].

Wood, N. (2001). The Health Project Book : a Handbook for New Researchers in the Field of Health. London: Routledge.

World Bank (2017). Nigeria | Data. [online] Worldbank.org. Available at: https://data.worldbank.org/country/nigeria [Accessed 8 Apr. 2021].

Yamane, T., (1967). Statistics: An Introductory Analysis, 2nd edition, New York: Harper and Row.

Yu, L.X. (2008). Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control. Pharmaceutical Research, 25(4), pp.781-791.

Yu, X., Yu, L.X., Teng, Y., Gaglani, D.K., Rege, B.D. and Rosencrance, S. (2019). Implementation of Pharmaceutical Quality by Design in Wet Granulation. Handbook of Pharmaceutical Wet Granulation, pp.703-733.

Zikmund, W. G. (2013). Business research methods. Mason, OH: South-Western.

Zomer, S., Zhang, J., Talwar, S., Chattoraj, S. and Hewitt, C. (2018). Multivariate monitoring for the industrialisation of a continuous wet granulation tableting process. International Journal of Pharmaceutics, 547(1-2), pp.506-519. A93