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■ Abbreviation / Long Form : CMC / chemistry, manufacturing and controls

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Total Number of Papers: 39
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Abbreviation:   CMC  (>> Co-occurring Abbreviation)
Long Form:   chemistry, manufacturing and controls
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No. Year Title Co-occurring Abbreviation
2019 Cutting-edge multi-level analytical and structural characterization of antibody-drug conjugates: present and future. ADCs, CQAs, DAR, DLD
2019 Innovation in Chemistry, Manufacturing, and Controls-A Regulatory Perspective From Industry. ---
2019 Pharmaceutical "New Prior Knowledge": Twenty-First Century Assurance of Therapeutic Equivalence. NDA, NPK
2018 Next Generation Biopharmaceuticals: Product Development. CQAs, mAbs
2018 Q-marker based strategy for CMC research of Chinese medicine: A case study of Panax Notoginseng saponins. CM, CPPs, PNS, Q-marker
2018 Risk-Based Comparability Assessment for Monoclonal Antibodies During Drug Development: A Clinical Pharmacology Perspective. mAb, PD, PK
2018 The End of Phase 3 Clinical Trials in Biosimilars Development? ---
2017 A Bioactive Chemical Markers Based Strategy for Quality Assessment of Botanical Drugs: Xuesaitong Injection as a Case Study. BCM, BD, XST
2017 Advancements in Understanding Immunogenicity of Biotherapeutics in the Intraocular Space. ADAs
10  2017 The Jordan Food and Drug Administration: Comparison of its Registration Process with Australia, Canada, Saudi Arabia and Singapore. CPP, GRevPs, HSA, JFDA, SFDA, TGA
11  2017 [A strategy of constructing the technological system for quality control of Chinese medicine based on process control and management]. CM, TCM
12  2017 [Consideration about chemistry, manufacture and control (CMC) key problems in simplified registration of classical traditional Chinese medicine excellent prescriptions]. cTCMeP, RDETP, TCM
13  2016 A Quality by Design Approach to Developing and Manufacturing Polymeric Nanoparticle Drug Products. QbD
14  2016 Building the design, translation and development principles of polymeric nanomedicines using the case of clinically advanced poly(lactide(glycolide))-poly(ethylene glycol) nanotechnology as a model: An industrial viewpoint. ---
15  2016 Chemistry, manufacturing and control (CMC) and clinical trial technical support for influenza vaccine manufacturers. BARDA, BCHT, DCVMs, GAP, IVAC, WHO's
16  2016 Investigational New Drug applications: a 1-year pilot study on rates and reasons for clinical hold. CDER, FDA, FY, INDs
17  2015 Development of Statistical Methods for Analytical Similarity Assessment. CQAs, FDA, QAs
18  2015 Extent and content of data for regulatory submissions: First-in-human and marketing authorization--Viewpoint of US industry. CAT, EMA, FDA
19  2015 Generic Pharmaceutical Association (GPhA) - 2015 CMC Workshop (June 9-10, 2015 - Bethesda, Maryland, USA). ANDAs, CDER, GPhA, OGD, OPQ
20  2015 Pre-Investigational New Drug Meetings With the FDA: Evaluation of Meeting Content and Characteristics of Applications for New Drug and Biologic Products. CDT, PIND
21  2014 Development of Taiwan's strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations. ---
22  2014 Nanomedicine drug development: a scientific symposium entitled "Charting a roadmap to commercialization". ---
23  2014 World Antibody-Drug Conjugate Summit, October 15-16, 2013, San Francisco, CA. WADC
24  2012 Passive transdermal systems whitepaper incorporating current chemistry, manufacturing and controls (CMC) development principles. MTC
25  2011 Consistent manufacturing and quality control of a highly complex recombinant polyclonal antibody product for human therapeutic use. rpAb
26  2010 Biotech outsourcing strategies cmc--biologics stream. June 17, 2010, Copenhagen, Denmark. BOS, CROs
27  2010 Development of mass spectrometry based techniques for the identification and determination of compositional variability in recombinant polyclonal antibody products. LC-MS
28  2009 European Medicines Agency workshop on biosimilar monoclonal antibodies: July 2, 2009, London, UK. EMEA, mAbs
29  2009 Instrumentation and radiopharmaceutical validation. FDA, GMP, PET
30  2008 Pharmaceutical quality by design: product and process development, understanding, and control. ANDAs, QbD
31  2006 Review of F-FDG Synthesis and Quality Control. BP, EP, TBA, USP
32  2005 Advancing TB vaccines to Phase I clinical trials in the US: regulatory/manufacturing/licensing issues. FDA, IND
33  2005 Efaproxiral: GSJ 61, JP 4, KDD 86, RS 4, RSR 13. CIT, NBCC, NSCLC, WBRT
34  2003 Compliance issues in manufacturing of drugs. ---
35  2002 Comparison of various requirements of the quality assurance procedures for (18)F-FDG injection. EP, FDA, QA, USP
36  1999 "Guidance for industry: content and format of chemistry, manufacturing and controls information and establishment description information for a biological in vitro diagnostic product;" availability. Food and Drug Administration, HHS. Notice. FDA
37  1999 "Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and for the Completion of the Form FDA 356h, 'Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use;'" availability. Food and Drug Administration, HHS. Notice. BLA, FDA
38  1999 "Guidance for Industry: On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test"; availability. Food and Drug Administration, HHS. Notice. FDA
39  1994 Regulatory aspects of modifications to innovator bronchodilator metered dose inhalers and development of generic substitutes. ANDA, NDA