<?xml version="1.0" encoding="UTF-8"?><doi_batch version="4.3.7" xmlns="http://www.crossref.org/schema/4.3.7" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="http://www.crossref.org/schema/4.3.7 http://www.crossref.org/schema/deposit/crossref4.3.7.xsd">
		<head>
		<doi_batch_id>eamdacademy.org-gyKp-1792216931-n279199728</doi_batch_id>
		<timestamp>1792216931</timestamp>
		<depositor>
			<depositor_name>Eurasian Academy of Medicine and Dentistry</depositor_name>
			<email_address>info@eamdacademy.org</email_address>
		</depositor>
		<registrant>Eurasian Academy of Medicine and Dentistry</registrant>
	</head>
	<body>
		<journal>
			<journal_metadata>
				<full_title>Journal of Applied Pharmaceutical Technologies and Systems</full_title>
				<abbrev_title>J Appl Pharm Technol Syst</abbrev_title>
				<issn>3149-9589</issn>
			</journal_metadata>
			<journal_issue>
				<publication_date>
					<year>2025</year>
				</publication_date>
				<journal_volume>
					<volume>4</volume>
				</journal_volume>
				<issue>1</issue>
			</journal_issue>
			<journal_article publication_type="full_text">
				<titles>
					<title>Designing Pharmaceutical Technologies for Resilience against Supply, Process, and Patient-Level Variability</title>
				</titles>
								<contributors>
          					<person_name sequence="first" contributor_role="author">
            <given_name>Sanjay</given_name>
            <surname>Kulkarni</surname>
					</person_name>
          					<person_name sequence="additional" contributor_role="author">
            <given_name>Meenal</given_name>
            <surname>Joshi</surname>
					</person_name>
          					<person_name sequence="additional" contributor_role="author">
            <given_name>Rohan</given_name>
            <surname>Patil</surname>
					</person_name>
          					<person_name sequence="additional" contributor_role="author">
            <given_name>Aniket</given_name>
            <surname>Deshmukh</surname>
					</person_name>
          				</contributors>
								<publication_date>
					<year>2025</year>
				</publication_date>
				<doi_data>
					<doi>10.68159/n279199728</doi>
					<resource>https://eamdacademy.org/pub/journal/3/article/n279199728</resource>
				</doi_data>
				<citation_list>
          					<citation key="rk-10.68159/n279199728-f7474e47-6cdb-4c38-9d44-bcd417c90e85">
					  <unstructured_citation>Tucker EL, Daskin MS. Pharmaceutical supply chain reliability and effects on drug shortages. Comput Ind Eng. 2022;169:108258.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-a9cd4926-fb94-475b-82eb-7d6d0b50146b">
					  <unstructured_citation>van Oorschot KE, Van Wassenhove LN, Jahre M, Selviaridis K, de Vries H. Drug shortages: A systems view of the current state. Decis Sci. 2022;53(6):969-84.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-6f52875a-be37-41ed-9585-1a012c9f0f0c">
					  <unstructured_citation>Vann Yaroson E, Breen L, Hou J, Sowter J. Examining the impact of resilience strategies in mitigating medicine shortages in the United Kingdom pharmaceutical supply chain. Benchmarking. 2024;31(3):683-706.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-7432e6a9-5aad-4673-91cd-20f4154bc293">
					  <unstructured_citation>Stauffer F, Vanhoorne V, Pilcer G, Chavez PF, Rome S, Schubert MA, et al. Raw material variability of an active pharmaceutical ingredient and its relevance for processability in secondary continuous pharmaceutical manufacturing. Eur J Pharm Biopharm. 2018;127:92-103.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-d9cf0d43-a6f9-4766-b305-66544d739f7f">
					  <unstructured_citation>Stauffer F, Vanhoorne V, Pilcer G, Chavez PF, Vervaet C, De Beer T. Managing API raw material variability in a continuous manufacturing line–Prediction of process robustness. Int J Pharm. 2019;569:118525.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-6b3053f7-4e82-48c0-959e-afaf8bdd1b44">
					  <unstructured_citation>Karttunen AP, Wikström H, Tajarobi P, Fransson M, Sparén A, Marucci M, et al. Comparison between integrated continuous direct compression line and batch processing–effect of raw material properties. Eur J Pharm Sci. 2019;133:40-53.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-1ff92159-5e35-4e00-9b47-099e5865dd94">
					  <unstructured_citation>Portier C, Vigh T, Di Pretoro G, Leys J, Klingeleers D, De Beer T, et al. Continuous twin screw granulation: impact of microcrystalline cellulose batch-to-batch variability during granulation and drying–a QbD approach. Int J Pharm X. 2021;3:100077.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-403faf85-46b9-4936-8af2-0d2d1ec1f8ba">
					  <unstructured_citation>Menditto E, Orlando V, De Rosa G, Minghetti P, Musazzi UM, Cahir C, et al. Patient-centric pharmaceutical drug product design—the impact on medication adherence. Pharmaceutics. 2020;12(1):44.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-399296ac-8093-4cc0-95ac-f51a3b817931">
					  <unstructured_citation>Stegemann S. Patient-centric drug product design in modern drug delivery as an opportunity to increase safety and effectiveness. Expert Opin Drug Deliv. 2018;15(6):619-27.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-28808b9d-a97a-492b-b2fd-6f002cce0af8">
					  <unstructured_citation>Stevenson J, Poker R, Schoss J, Campbell M, Everitt C, Holly B, et al. Pharmaceutical and biotech industry perspectives on optimizing patient experience and treatment adherence through subcutaneous drug delivery design. Adv Drug Deliv Rev. 2024;209:115322.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-fc3a6bc8-83ac-450c-ab3f-15c476e95040">
					  <unstructured_citation>Grangeia HB, Silva C, Simoes SP, Reis MS. Quality by design in pharmaceutical manufacturing: a systematic review of current status, challenges and future perspectives. Eur J Pharm Biopharm. 2020;147:19-37.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-70b1b01d-7442-44e1-ba36-db91852e8d94">
					  <unstructured_citation>Patriarca R, Bergström J, Di Gravio G, Costantino F. Resilience engineering: current status of the research and future challenges. Saf Sci. 2018;102:79-100.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-d784bebd-cb1b-44a4-a902-4f9db088e790">
					  <unstructured_citation>Woods DD. The theory of graceful extensibility: basic rules that govern adaptive systems. Environ Syst Decis. 2018;38(4):433-57.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-ed077e3f-7045-4d33-98ae-41cb424e9e87">
					  <unstructured_citation>Zio E. The future of risk assessment. Reliab Eng Syst Saf. 2018;177:176-90.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-4fbf3f1d-b2ad-4844-a1eb-76b002705e51">
					  <unstructured_citation>Jelsch M, Roggo Y, Kleinebudde P, Krumme M. Model predictive control in pharmaceutical continuous manufacturing: a review from a user’s perspective. Eur J Pharm Biopharm. 2021;159:137-42.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-db177d8a-f06e-468b-bd24-bebfc21c264e">
					  <unstructured_citation>Su Q, Ganesh S, Moreno M, Bommireddy Y, Gonzalez M, Reklaitis GV, et al. A perspective on Quality-by-Control in pharmaceutical continuous manufacturing. Comput Chem Eng. 2019;125:216-31.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-57e67043-d0f8-4449-bcc6-609792427f54">
					  <unstructured_citation>Arden NS, Fisher AC, Tyner K, Yu LX, Lee SL, Kopcha M. Industry 4.0 for pharmaceutical manufacturing: preparing for smart factories of the future. Int J Pharm. 2021;602:120554.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-6e98f1ed-e706-4529-80d0-875999602e86">
					  <unstructured_citation>Vanhoorne V, Vervaet C. Recent progress in continuous manufacturing of oral solid dosage forms. Int J Pharm. 2020;579:119194.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-f843d4cf-5d58-44c9-8b95-d5f34abe1b65">
					  <unstructured_citation>Lee WB, Widjaja E, Heng PW, Chan LW. De-risking excipient particle size distribution variability with automated robust mixing: integrating quality by design and process analytical technology. Eur J Pharm Biopharm. 2020;157:9-24.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-c1e00c49-2fe1-4aaf-9607-ef4bbde18d79">
					  <unstructured_citation>Bhaskar A, Barros FN, Singh R. Development and implementation of an advanced model predictive control system into continuous pharmaceutical tablet compaction process. Int J Pharm. 2017;534(1–2):159-78.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-3773e123-da73-4ac1-8583-1b4b40ed7438">
					  <unstructured_citation>Pauli V, Kleinebudde P, Krumme M. Predictive model-based process start-up in pharmaceutical continuous granulation and drying. Pharmaceutics. 2020;12(1):67.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-8bd812ce-c030-41f4-8a0d-f80b19b11b2e">
					  <unstructured_citation>Huang YS, Sheriff MZ, Bachawala S, Gonzalez M, Nagy ZK, Reklaitis GV. Evaluation of a combined MHE-NMPC approach to handle plant-model mismatch in a rotary tablet press. Processes. 2021;9(9):1612.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-db9e799c-7371-45d9-8210-d64b2931dc0c">
					  <unstructured_citation>Stegemann S, Sheehan L, Rossi A, Barrett A, Paudel A, Crean A, et al. Rational and practical considerations to guide a target product profile for patient-centric drug product development with measurable patient outcomes–a proposed roadmap. Eur J Pharm Biopharm. 2022;177:81-8.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-606b1264-c729-465b-a7e3-bb0fcf2a049b">
					  <unstructured_citation>Tian G, Koolivand A, Arden NS, Lee S, O’Connor TF. Quality risk assessment and mitigation of pharmaceutical continuous manufacturing using flowsheet modeling approach. Comput Chem Eng. 2019;129:106508.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-32e5e75a-c70b-4a94-97e3-b631dbce4e8a">
					  <unstructured_citation>Vargas JM, Nielsen S, Cárdenas V, Gonzalez A, Aymat EY, Almodovar E, et al. Process analytical technology in continuous manufacturing of a commercial pharmaceutical product. Int J Pharm. 2018;538(1–2):167-78.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-df975ec6-131a-4295-b8d5-2e43c543069e">
					  <unstructured_citation>Waeytens R, Van Hauwermeiren D, Grymonpré W, Nopens I, De Beer T. A framework for the in silico assessment of the robustness of an MPC in a CDC line in function of process variability. Int J Pharm. 2024;658:124137.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-970373c2-2647-4f46-84ed-ca9b5904e39a">
					  <unstructured_citation>Vega-Zambrano C, Diangelakis NA, Charitopoulos VM. Data-driven model predictive control for continuous pharmaceutical manufacturing. Int J Pharm. 2025;672:125322.</unstructured_citation>
											</citation>
          					<citation key="rk-10.68159/n279199728-1f19bbcf-9231-412d-979b-43d1f105edbe">
					  <unstructured_citation>Nasr MM, Krumme M, Matsuda Y, Trout BL, Badman C, Mascia S, et al. Regulatory perspectives on continuous pharmaceutical manufacturing: moving from theory to practice. J Pharm Sci. 2017;106(11):3199-206.</unstructured_citation>
											</citation>
          				</citation_list>
			</journal_article>
		</journal>
	</body>
</doi_batch>
