Research map: Development of a robust optimization strategy for primary drying in lyophilization, considering intra- and inter-batch variability

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  1. Mass and Heat Transfer in Vial Freeze-Drying of Pharmaceuticals: Role of the Vial · Michael Jon Pikal · 1984 · 349 citations · Cited by this paper
  2. Formulation development and evaluation of nasal in situ gel of promethazine hydrochloride- part II: Pharmacokinetic evaluation and bioavailability studies · 2026 · Related
  3. The collapse temperature in freeze drying: Dependence on measurement methodology and rate of water removal from the glassy phase · Michael Jon Pikal · 1990 · 313 citations · Cited by this paper
  4. From particle to performance: Linking size-dependent swelling to disintegration mechanisms in natural plant product tablets · 2026 · Related
  5. Development of simplified models for the freeze-drying process and investigation of the optimal operating conditions · Salvatore A. Velardi · 2008 · 190 citations · Cited by this paper
  6. Perfluorocarbon–liquid interface culture method enhances mucus production and allows evaluation of drug permeability through the mucus layer · 2026 · Related
  7. Modeling of the primary and secondary drying stages of the freeze drying of pharmaceutical products in vials: Numerical results obtained from the solution of a dynamic and spatially multi-dimensional lyophilization model for different operational policies · Paul Sheehan · 1998 · 152 citations · Cited by this paper
  8. In-die compressibility as a surrogate for lubrication-induced changes in tabletability · 2026 · Related
  9. Distributionally robust optimization for planning and scheduling under uncertainty · Chao Shang · 2017 · 148 citations · Cited by this paper
  10. Rational design, expression and refolding of a novel bispecific antibody to simultaneously target VEGF-A and Ang-2 for inhibition of angiogenesis · 2026 · Related
  11. A computational model for finite element analysis of the freeze-drying process · W. J. Mascarenhas · 1997 · 138 citations · Cited by this paper
  12. Efficacy of ultraviolet irradiation of pharmaceutical excipients in mitigating N-nitrosamine generation · 2026 · Related
  13. Advanced approach to build the design space for the primary drying of a pharmaceutical freeze‐drying process · Davide Fissore · 2011 · 114 citations · Cited by this paper
  14. Elucidation of intermolecular interaction patterns in quaternary solid dispersion complexes of enzalutamide · 2026 · Related
  15. Economic Analysis of a Freeze-Drying Cycle · Lorenzo Stratta · 2020 · 104 citations · Cited by this paper
  16. Niclosamide ethanolamine induces malignant phyllodes tumor cell death via mTOR-TFEB axis-mediated lysosomal biogenesis and functional uncoupling · 2026 · Related
  17. Freeze drying process: real time model and optimization · Edinara Adelaide Boss · 2004 · 93 citations · Cited by this paper
  18. Correlation between protein-polydimethylsiloxane visible particle formation and computationally derived antibody surface properties · 2026 · Related
  19. Choked flow and importance of Mach I in freeze-drying process design · Sajal Manubhai Patel · 2010 · 93 citations · Cited by this paper
  20. Identification of a diastereomer of penicilloic acid during acid-mediated degradation of 6-aminopenicillanic acid · 2026 · Related
  21. Rapid determination of dry layer mass transfer resistance for various pharmaceutical formulations during primary drying using product temperature profiles · Wei Y. Kuu · 2006 · 79 citations · Cited by this paper
  22. Freeze-Drying of Pharmaceutical Crystalline and Amorphous Solutes in Vials: Dynamic Multi-Dimensional Models of the Primary and Secondary Drying Stages and Qualitative Features of the Moving Interface · A.I. Liapis · 1995 · 78 citations · Cited by this paper
  23. Quality by design: optimization of a freeze-drying cycle via design space in case of heterogeneous drying behavior and influence of the freezing protocol · Roberto Pisano · 2012 · 77 citations · Cited by this paper
  24. Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment · Jelena Djuriš · 2017 · 69 citations · Cited by this paper
  25. Freeze-Drying Cycle Optimization Using Model Predictive Control Techniques · Roberto Pisano · 2011 · 59 citations · Cited by this paper
  26. Prediction of Ice Crystal Size Distribution after Freezing of Pharmaceutical Solutions · Andrea Arsiccio · 2017 · 57 citations · Cited by this paper
  27. Practical Advice on Scientific Design of Freeze-Drying Process: 2023 Update · Serguei Tchessalov · 2023 · 57 citations · Cited by this paper
  28. Uncertainty analysis as essential step in the establishment of the dynamic Design Space of primary drying during freeze-drying · Séverine Thérèse F. C. Mortier · 2016 · 56 citations · Cited by this paper
  29. Primary Drying Optimization in Pharmaceutical Freeze-Drying: A Multivial Stochastic Modeling Framework · Gabriele Bano · 2020 · 49 citations · Cited by this paper
  30. Use of a soft sensor for the fast estimation of dried cake resistance during a freeze-drying cycle · Serena Bosca · 2013 · 45 citations · Cited by this paper
  31. Impact of Natural Variations in Freeze-Drying Parameters on Product Temperature History: Application of Quasi Steady-State Heat and Mass Transfer and Simple Statistics · Michael Jon Pikal · 2018 · 41 citations · Cited by this paper
  32. Scale-up and Process Transfer of Freeze-Drying Recipes · Davide Fissore · 2011 · 39 citations · Cited by this paper
  33. Optimization under uncertainty in chemical engineering: Comparative evaluation of unscented transformation methods and cubature rules · Johannes Maußner · 2018 · 38 citations · Cited by this paper
  34. Model-Based Real Time Operation of the Freeze-Drying Process · Carlos Vilas · 2020 · 38 citations · Cited by this paper
  35. LyoPRONTO: an Open-Source Lyophilization Process Optimization Tool · Gayathri Shivkumar · 2019 · 36 citations · Cited by this paper
  36. Determination of the dried product resistance variability and its influence on the product temperature in pharmaceutical freeze-drying · Bernadette Scutellà · 2018 · 33 citations · Cited by this paper
  37. Model development and prediction of particle size distribution, density and friability of a comilling operation in a continuous pharmaceutical manufacturing process · Nirupaplava Metta · 2018 · 30 citations · Cited by this paper
  38. Robust Process Design in Pharmaceutical Manufacturing under Batch-to-Batch Variation · Xiangzhong Xie · 2019 · 30 citations · Cited by this paper
  39. Experimental Aspects of Measuring the Vial Heat Transfer Coefficient in Pharmaceutical Freeze-Drying · Lindsay A. Wegiel · 2018 · 29 citations · Cited by this paper

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