المؤلفون: DiMasi JA; Tufts Center for the Study of Drug Development, Tufts University, Boston, Massachusetts. Electronic address: joseph.dimasi@tufts.edu., Smith Z; Tufts Center for the Study of Drug Development, Tufts University, Boston, Massachusetts., Getz KA; Tufts Center for the Study of Drug Development, Tufts University, Boston, Massachusetts.

المصدر: Clinical therapeutics [Clin Ther] 2018 Jun; Vol. 40 (6), pp. 963-972. Date of Electronic Publication: 2018 May 11.

نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't

بيانات الدورية: Publisher: Excerpta Medica Country of Publication: United States NLM ID: 7706726 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-114X (Electronic) Linking ISSN: 01492918 NLM ISO Abbreviation: Clin Ther Subsets: MEDLINE

مواضيع طبية MeSH: Drug Development/*economics , Outsourced Services/*economics, Commerce ; Costs and Cost Analysis ; Drug Industry

المؤلفون: Jamei M; Certara UK Limited (Simcyp Division), Sheffield, UK. Electronic address: masoud.jamei@certara.com., Abrahamsson B; Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg, Sweden., Brown J; Bristol-Myers Squibb, Reeds Lane, Moreton, Wirral CH46 1QW, UK., Bevernage J; Janssen Research & Development, Small Molecules Pharmaceutical Development, Biopharmaceutics, Beerse, Belgium., Bolger MB; Simulations Plus, Inc., Lancaster, CA, USA., Heimbach T; Pharmaceutical Sciences, Merck & Co., Inc., Kenilworth, NJ, USA., Karlsson E; Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg, Sweden., Kotzagiorgis E; European Medicines Agency, Amsterdam, the Netherlands., Lindahl A; Swedish Medical Products Agency, Uppsala, Sweden., McAllister M; Pfizer Global Research & Development, Sandwich, UK., Mullin JM; Simulations Plus, Inc., Lancaster, CA, USA., Pepin X; New Modalities & Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK., Tistaert C; Janssen Research & Development, Small Molecules Pharmaceutical Development, Biopharmaceutics, Beerse, Belgium., Turner DB; Certara UK Limited (Simcyp Division), Sheffield, UK., Kesisoglou F; Pharmaceutical Sciences, Merck & Co., Inc., Kenilworth, NJ, USA.

المصدر: European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V [Eur J Pharm Biopharm] 2020 Oct; Vol. 155, pp. 55-68. Date of Electronic Publication: 2020 Aug 08.

نوع المنشور: Journal Article; Review

بيانات الدورية: Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 9109778 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-3441 (Electronic) Linking ISSN: 09396411 NLM ISO Abbreviation: Eur J Pharm Biopharm Subsets: MEDLINE

مواضيع طبية MeSH: Computer Simulation*/trends , Models, Biological*, Drug Development/*methods , Pharmaceutical Preparations/*metabolism, Administration, Oral ; Animals ; Biopharmaceutics/methods ; Biopharmaceutics/trends ; Drug Development/trends ; Drug Liberation/drug effects ; Drug Liberation/physiology ; Forecasting ; Gastrointestinal Tract/drug effects ; Gastrointestinal Tract/metabolism ; Humans ; Intestinal Absorption/drug effects ; Intestinal Absorption/physiology ; Pharmaceutical Preparations/administration & dosage ; Pharmaceutical Preparations/chemical synthesis ; Solubility

المؤلفون: Van Manen-Brush K; GlaxoSmithKline, Biopharmaceutical Analytical Sciences, Collegeville, PA 19475, USA., Zeitler J; GlaxoSmithKline, Biopharmaceutical Analytical Sciences, Collegeville, PA 19475, USA., White JR; GlaxoSmithKline, Biopharmaceutical Analytical Sciences, Collegeville, PA 19475, USA., Younge P; Protein Simple, Simple Plex Development, Wallingford, CT 06482, USA., Willis S; Protein Simple, Simple Plex Development, Wallingford, CT 06482, USA., Jones M; GlaxoSmithKline, Biopharmaceutical Analytical Sciences, Collegeville, PA 19475, USA.

المصدر: BioTechniques [Biotechniques] 2020 Sep; Vol. 69 (3), pp. 186-192. Date of Electronic Publication: 2020 Jul 03.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Future Science Country of Publication: England NLM ID: 8306785 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1940-9818 (Electronic) Linking ISSN: 07366205 NLM ISO Abbreviation: Biotechniques Subsets: MEDLINE

مواضيع طبية MeSH: Drug Development* , Enzyme-Linked Immunosorbent Assay*, Microfluidics/*methods , Proteins/*isolation & purification, Animals ; CHO Cells/chemistry ; Cricetinae ; Cricetulus ; Proteins/chemistry

المؤلفون: Farid SS; The Advanced Centre for Biochemical Engineering, Department of Biochemical Engineering, University College London , London, UK., Baron M; The Advanced Centre for Biochemical Engineering, Department of Biochemical Engineering, University College London , London, UK., Stamatis C; The Advanced Centre for Biochemical Engineering, Department of Biochemical Engineering, University College London , London, UK., Nie W; The Advanced Centre for Biochemical Engineering, Department of Biochemical Engineering, University College London , London, UK., Coffman J; Biopharmaceutical Development, AstraZeneca , Gaithersburg, MD, USA.

المصدر: MAbs [MAbs] 2020 Jan-Dec; Vol. 12 (1), pp. 1754999.

نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't

بيانات الدورية: Publisher: Taylor & Francis Country of Publication: United States NLM ID: 101479829 Publication Model: Print Cited Medium: Internet ISSN: 1942-0870 (Electronic) Linking ISSN: 19420862 NLM ISO Abbreviation: MAbs Subsets: MEDLINE

مواضيع طبية MeSH: Antibodies, Monoclonal/*therapeutic use , Benchmarking/*methods , Biological Products/*therapeutic use , Drug Approval/*methods , Drug Development/*methods , Drug Industry/*methods, Benchmarking/economics ; Clinical Trials as Topic/economics ; Drug Approval/economics ; Drug Costs/statistics & numerical data ; Drug Development/economics ; Drug Evaluation, Preclinical/economics ; Drug Industry/economics ; Humans ; Models, Economic ; Pharmaceutical Preparations/economics ; Research/economics ; Research/statistics & numerical data ; Technology, Pharmaceutical/economics ; Technology, Pharmaceutical/methods

المؤلفون: Halley J; UCB, Biomolecular Characterisation Sciences, 216 Bath Road, Slough, Berkshire SL1 3WE, UK. Electronic address: Jennifer.Halley@ucb.com., Chou YR; Merck & Co. Inc., Analytical Research & Development, K-15 B419c, 2000 Galloping Hill Road, Kenilworth, New Jersey 070330., Cicchino C; Regeneron, 81 Columbia Turnpike, Rensselaer, New York 12144., Huang M; Pfizer, BTx Pharm Sci Pharmaceutical R&D, 1 Burtt Road, Andover, Massachusetts 01810., Sharma V; Genentech, A Member of Roche Group, 1 DNA Way, South San Francisco, California 94080., Tan NC; Takeda Pharmaceuticals International Co., 300 Massachusetts Avenue, Cambridge, Massachusetts 02139., Thakkar S; Janssen Research & Development, Large Molecule Drug Product Development, 200 Great Valley Parkway, Malvern, Pennsylvania 19355., Zhou LL; AbbVie Bioresearch Center, 100 Research Dr, Worcester, Massachusetts 01605., Al-Azzam W; GlaxoSmithKline R&D, 1250 S. Collegeville Road, Collegeville, Pennsylvania 19426., Cornen S; Sanofi, Biologics Development, 13, Quai Jules Guesde - BP 14, 94403 Vitry-sur-Seine Cedex, France., Gauden M; Lonza Biologics, 228 Bath Road, Slough, SL1 4DX, UK., Gu Z; Alexion Pharmaceuticals, 100 College St., New Haven, Connecticut 06510., Kar S; Bristol-Myers Squibb, Molecular and Analytical Development, 311 Pennington-Rocky Hill Road, Pennington, New Jersey 08534., Lazar AC; ImmunoGen, Inc., Analytical and Pharmaceutical Development, 830 Winter Street, Waltham, Massachusetts 02451., Mehndiratta P; Celgene, Analytical Development, 556 Morris Ave, Summit, New Jersey 07901., Smith J; Lonza Biologics, 228 Bath Road, Slough, SL1 4DX, UK., Sosic Z; Biogen, Analytical Development, Cambridge, Massachusetts 02142., Weisbach P; ImmunoGen, Inc., Analytical and Pharmaceutical Development, 830 Winter Street, Waltham, Massachusetts 02451., Stokes ESE; BioPhorum Operations Group, Sharrow Vale Road, Sheffield, S11 8YZ, UK.

المصدر: Journal of pharmaceutical sciences [J Pharm Sci] 2020 Jan; Vol. 109 (1), pp. 6-21. Date of Electronic Publication: 2019 Sep 26.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Elsevier Country of Publication: United States NLM ID: 2985195R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1520-6017 (Electronic) Linking ISSN: 00223549 NLM ISO Abbreviation: J Pharm Sci Subsets: MEDLINE

مواضيع طبية MeSH: Surveys and Questionnaires*, Antibodies, Monoclonal/*metabolism , Biological Products/*metabolism , Chemistry, Pharmaceutical/*methods , Drug Development/*methods , Drug Industry/*methods, Antibodies, Monoclonal/chemistry ; Biological Products/chemistry ; Freezing/adverse effects ; Humans ; Oxidative Stress/physiology

المؤلفون: Singh R; Scientific Insights Lab, West Pharmaceutical Services, Inc., Exton, Pennsylvania 19341. Electronic address: Ranjana.Singh@westpharma.com., Waxman L; Scientific Insights Lab, West Pharmaceutical Services, Inc., Exton, Pennsylvania 19341.

المصدر: Journal of pharmaceutical sciences [J Pharm Sci] 2020 Jan; Vol. 109 (1), pp. 206-210. Date of Electronic Publication: 2019 Sep 20.

نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't

بيانات الدورية: Publisher: Elsevier Country of Publication: United States NLM ID: 2985195R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1520-6017 (Electronic) Linking ISSN: 00223549 NLM ISO Abbreviation: J Pharm Sci Subsets: MEDLINE

مواضيع طبية MeSH: Biological Products*/administration & dosage , Biological Products*/standards , Syringes*/standards, Drug Development/*methods , Drug Industry/*methods , Drug Packaging/*methods, Antibodies, Monoclonal/administration & dosage ; Chromatography, Gel/methods ; Chromatography, Gel/standards ; Drug Development/standards ; Drug Industry/standards ; Drug Packaging/standards ; Humans ; Protein Aggregates/physiology

المؤلفون: Helbig C; Coriolis Pharma Research, Fraunhoferstr. 18 b, 82152 Martinsried, Germany., Ammann G; Coriolis Pharma Research, Fraunhoferstr. 18 b, 82152 Martinsried, Germany., Menzen T; Coriolis Pharma Research, Fraunhoferstr. 18 b, 82152 Martinsried, Germany., Friess W; Department of Pharmacy, Ludwig-Maximilians-Universität München, Pharmaceutical Technology and Biopharmaceutics, Butenandtstr. 5-13, 81337 Munich, Germany., Wuchner K; Janssen Research and Development, DPD&S Biotherapeutics Development, Hochstr. 201, 8205 Schaffhausen, Switzerland., Hawe A; Coriolis Pharma Research, Fraunhoferstr. 18 b, 82152 Martinsried, Germany. Electronic address: andrea.hawe@coriolis-pharma.com.

المصدر: Journal of pharmaceutical sciences [J Pharm Sci] 2020 Jan; Vol. 109 (1), pp. 264-276. Date of Electronic Publication: 2019 Mar 23.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Elsevier Country of Publication: United States NLM ID: 2985195R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1520-6017 (Electronic) Linking ISSN: 00223549 NLM ISO Abbreviation: J Pharm Sci Subsets: MEDLINE

مواضيع طبية MeSH: Protein Aggregates*, Antibodies, Monoclonal/*chemistry , Biopharmaceutics/*methods , Drug Development/*methods , Image Processing, Computer-Assisted/*methods , Pharmaceutical Preparations/*chemistry, High-Throughput Screening Assays ; Particle Size ; Polysorbates/chemistry ; Polystyrenes/chemistry ; Silicone Oils/chemistry ; Syringes

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المؤلفون: Pathak SM; Certara UK Limited, Simcyp Division, Level 2-Acero, Sheffield, S1 2BJ, UK. Electronic address: shriram.pathak@certara.com., Schaefer KJ; Pharmaceutical Development, Boehringer-Ingelheim Pharma GmbH & Co. KG, Germany., Jamei M; Certara UK Limited, Simcyp Division, Level 2-Acero, Sheffield, S1 2BJ, UK., Turner DB; Certara UK Limited, Simcyp Division, Level 2-Acero, Sheffield, S1 2BJ, UK.

المصدر: Journal of pharmaceutical sciences [J Pharm Sci] 2019 Apr; Vol. 108 (4), pp. 1604-1618. Date of Electronic Publication: 2018 Nov 23.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Elsevier Country of Publication: United States NLM ID: 2985195R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1520-6017 (Electronic) Linking ISSN: 00223549 NLM ISO Abbreviation: J Pharm Sci Subsets: MEDLINE

مواضيع طبية MeSH: Models, Biological*, Biopharmaceutics/*methods , Drug Development/*methods, Administration, Oral ; Computer Simulation ; Dipyridamole/administration & dosage ; Dipyridamole/pharmacokinetics ; Drug Liberation ; Duodenum/metabolism ; Humans ; Intestinal Absorption ; Intestinal Mucosa/metabolism ; Solubility ; Workflow

المؤلفون: Esteban E; Evidence-Based Therapeutic Group, Clinical Pharmacology, Universidad de la Sabana, Chia, Colombia., Bustos RH; Evidence-Based Therapeutic Group, Clinical Pharmacology, Universidad de la Sabana, Chia, Colombia., García JC; Evidence-Based Therapeutic Group, Clinical Pharmacology, Universidad de la Sabana, Chia, Colombia., Jáuregui E; Riesgo de Fractura S.A. Cayre IPS, Bogota, Colombia.

المصدر: Current clinical pharmacology [Curr Clin Pharmacol] 2019; Vol. 14 (1), pp. 16-40.

نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't; Review

بيانات الدورية: Publisher: Bentham Science Publishers Ltd Country of Publication: United Arab Emirates NLM ID: 101273158 Publication Model: Print Cited Medium: Internet ISSN: 2212-3938 (Electronic) Linking ISSN: 15748847 NLM ISO Abbreviation: Curr Clin Pharmacol Subsets: MEDLINE

مواضيع طبية MeSH: Biosimilar Pharmaceuticals/*therapeutic use , Biotechnology/*legislation & jurisprudence , Drug Development/*legislation & jurisprudence , Drug Industry/*legislation & jurisprudence, Autoimmune Diseases/drug therapy ; Autoimmune Diseases/epidemiology ; Biotechnology/methods ; Drug Development/methods ; Drug Industry/methods ; Humans