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Journal Abstract Search

175 related items for PubMed ID: 29785887

  • 1. Quality by design, process analytical technology, GMP and regulatory affairs.
    Çelik M.
    Pharm Dev Technol; 2018 Jul; 23(6):553. PubMed ID: 29785887
    [No Abstract] [Full Text] [Related]

  • 2. Regulatory and quality considerations for continuous manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.
    Allison G, Cain YT, Cooney C, Garcia T, Bizjak TG, Holte O, Jagota N, Komas B, Korakianiti E, Kourti D, Madurawe R, Morefield E, Montgomery F, Nasr M, Randolph W, Robert JL, Rudd D, Zezza D.
    J Pharm Sci; 2015 Mar; 104(3):803-12. PubMed ID: 25830179
    [Abstract] [Full Text] [Related]

  • 3. "Obvious to try": a proper patentability standard in the pharmaceutical arts?
    Trask AV.
    Fordham Law Rev; 2008 Apr; 76(5):2625-68. PubMed ID: 18546581
    [No Abstract] [Full Text] [Related]

  • 4. [Pharmaceutical product quality control and good manufacturing practices].
    Hiyama Y.
    Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku; 2010 Apr; (128):1-16. PubMed ID: 21381389
    [Abstract] [Full Text] [Related]

  • 5. The central role of chemistry in 'quality by design' approaches to drug development.
    Grewal NK, Leadbeater NE.
    Future Med Chem; 2012 Sep; 4(14):1799-810. PubMed ID: 23043477
    [Abstract] [Full Text] [Related]

  • 6. [Guidelines for introducing new drugs for medical use in Poland and control of their quality].
    Danysz A.
    Pol Tyg Lek; 2012 Sep; 39(51-52):1673-4. PubMed ID: 6522321
    [No Abstract] [Full Text] [Related]

  • 7. Systems validation for parenteral clinical drugs--application to R&D and QC laboratories.
    Tetzlaff RF.
    J Parenter Sci Technol; 1983 Sep; 37(2):45-50. PubMed ID: 6345744
    [No Abstract] [Full Text] [Related]

  • 8. Guest editors' note: special issue on recent developments in statistical approaches for chemistry and manufacturing control (CMC) and quality-by-design(QbD).
    Tsong Y, Yang H.
    J Biopharm Stat; 2015 Sep; 25(2):233. PubMed ID: 25437635
    [No Abstract] [Full Text] [Related]

  • 9. WHO Expert Committee on Specifications for Pharmaceutical Preparations.
    World Health Organization.
    World Health Organ Tech Rep Ser; 2014 Sep; (986):1-387, back cover. PubMed ID: 24964711
    [Abstract] [Full Text] [Related]

  • 10. WHO Expert Committee on Specifications for Pharmaceutical Preparations.
    World Health Organization.
    World Health Organ Tech Rep Ser; 2009 Sep; (953):1-161. PubMed ID: 19621561
    [Abstract] [Full Text] [Related]

  • 11. A new roadmap for biopharmaceutical drug product development: Integrating development, validation, and quality by design.
    Martin-Moe S, Lim FJ, Wong RL, Sreedhara A, Sundaram J, Sane SU.
    J Pharm Sci; 2011 Aug; 100(8):3031-3043. PubMed ID: 21425164
    [Abstract] [Full Text] [Related]

  • 12. Comparison of the recovery spread in analytical development and routine quality control--based on the ICH quality guideline Q2B.
    Schepers U, El Deeb S, Ermer J, Wätzig H.
    J Pharm Biomed Anal; 2007 Jan 17; 43(2):708-10. PubMed ID: 16904281
    [Abstract] [Full Text] [Related]

  • 13. Best practices for extractables and leachables in orally inhaled and nasal drug products: an overview of the PQRI recommendations.
    Norwood DL, Paskiet D, Ruberto M, Feinberg T, Schroeder A, Poochikian G, Wang Q, Deng TJ, DeGrazio F, Munos MK, Nagao LM.
    Pharm Res; 2008 Apr 17; 25(4):727-39. PubMed ID: 18183477
    [Abstract] [Full Text] [Related]

  • 14. Quality Assurance and Quality Control, Part 2.
    Akers MJ.
    Int J Pharm Compd; 2015 Apr 17; 19(3):215-21. PubMed ID: 26714362
    [Abstract] [Full Text] [Related]

  • 15. A consortium-driven framework to guide the implementation of ICH M7 Option 4 control strategies.
    Barber C, Antonucci V, Baumann JC, Brown R, Covey-Crump E, Elder D, Elliott E, Fennell JW, Gallou F, Ide ND, Jordine G, Kallemeyn JM, Lauwers D, Looker AR, Lovelle LE, McLaughlin M, Molzahn R, Ott M, Schils D, Oestrich RS, Stevenson N, Talavera P, Teasdale A, Urquhart MW, Varie DL, Welch D.
    Regul Toxicol Pharmacol; 2017 Nov 17; 90():22-28. PubMed ID: 28822875
    [Abstract] [Full Text] [Related]

  • 16. Nanotechnology and therapeutic delivery: a drug regulation perspective.
    Sadrieh N, Tyner KM.
    Ther Deliv; 2010 Jul 17; 1(1):83-9. PubMed ID: 22816122
    [Abstract] [Full Text] [Related]

  • 17. Control systems engineering in continuous pharmaceutical manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.
    Myerson AS, Krumme M, Nasr M, Thomas H, Braatz RD.
    J Pharm Sci; 2015 Mar 17; 104(3):832-9. PubMed ID: 25546650
    [Abstract] [Full Text] [Related]

  • 18. Excipient variability and its impact on dosage form functionality.
    Dave VS, Saoji SD, Raut NA, Haware RV.
    J Pharm Sci; 2015 Mar 17; 104(3):906-15. PubMed ID: 25561249
    [Abstract] [Full Text] [Related]

  • 19. [Standardization as a basis planning and administration in drug industry and pharmacy (II)].
    Wagler M.
    Pharm Prax; 1970 Mar 17; 7():151-3. PubMed ID: 5469874
    [No Abstract] [Full Text] [Related]

  • 20. A Quality by Design Approach to Developing and Manufacturing Polymeric Nanoparticle Drug Products.
    Troiano G, Nolan J, Parsons D, Van Geen Hoven C, Zale S.
    AAPS J; 2016 Nov 17; 18(6):1354-1365. PubMed ID: 27631558
    [Abstract] [Full Text] [Related]

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