{"text_format":"2","workbook":"xls","n_sheets":1,"sheets":["report2"],"not_rendered":{"charts":0,"images":0,"macros":0,"external_links":1,"defined_names":1,"comments":0,"pivot_tables":0},"unopened":[],"bounds":{"document_bytes":16777216,"sheet_cells":100000,"run_cost":"one","rows_first":2000,"rows_last":500,"rows_between":2000,"halvings":0,"cell_chars":16384,"cell_head_chars":4096},"cells_cut":0,"cells_raw":0,"read":"whole","date_system":"1900","formulas":"cached_only"}

{"sheet":"report2","index":0,"n_rows":18,"n_cols":5,"rows_kept":18,"cut":false,"hidden":false,"merged":[[0,2,0,3],[0,4,0,5],[1,2,1,3],[1,4,1,5],[2,2,2,3],[2,4,2,5],[3,2,3,3],[4,2,4,3],[5,2,5,3],[6,2,6,3],[7,2,7,3],[8,2,8,3],[9,2,9,3],[12,2,12,3],[13,2,13,3],[15,2,15,3]],"flags":["formulas_cached_only"]}
[null,"1.","Record Nr.",null,"UNINA9910349446003321"]
[null,null,"Autore",null,"Pazhayattil Ajay"]
[null,null,"Titolo",null,"Solid Oral Dose Process Validation, Volume Two : Lifecycle Approach Application / / by Ajay Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Marzena Ingram, Jordan Collins"]
[null,null,"Pubbl/distr/stampa",null,"Cham : , : Springer International Publishing : , : Imprint : Springer, , 2019"]
[null,null,"ISBN",null,"3-030-27484-5"]
[null,null,"Edizione",null,"[1st ed. 2019.]"]
[null,null,"Descrizione fisica",null,"1 online resource (116 pages)"]
[null,null,"Collana",null,"AAPS Introductions in the Pharmaceutical Sciences, , 2522-834X"]
[null,null,"Disciplina",null,"615.19"]
[null,null,"Soggetti",null,"Pharmacology"]
[{"$nulls":4},"Pharmacy"]
[{"$nulls":4},"Pharmacology/Toxicology"]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,"Nota di contenuto",null,"Preface, Introduction, Chapter 1: Stage 1 Quality by Design Product Development QbD product development methodologies -- Chapter 2: Stage 1 Scale Up, Tech Transfer Process -- Considerations for process scale up and transfer -- Chapter 3: Stage 2 Batch determination, Sampling & Testing Plan -- PPQ batch determination method, scientifically supported sampling and testing plans -- Chapter 4: Stage 3A Continued Process Verification -- Stage 3A assessment methodology for newly launched products -- Chapter 5: Stage 3B Continued Process Verification -- Routine CPV monitoring plan for commercial products."]
[null,null,null,"Sommario/riassunto","The textbook addresses the lifecycle concepts (Stage 1, 2, 3) of Process Validation. Regulatory bodies such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. Organizations have an opportunity to harmonize and align PV activities for all regulated markets. The concepts discussed provides a direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Oral Dose Process Validation, Lifecycle Approach: Application, Volume Two and the companion Volume One, Solid Dose Process Validation, The Basics, also available as a set, provide directions and solutions for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential "]
[{"$nulls":4},"information for pharmaceutical professionals who use the process validation lifecycle approach. This set is published as a comprehensive solution for solid dose process validation."]