References
Workman J, Koch M, Veltkamp DJ (2003) Anal Chem 75(12):2859–2876
Lavine B, Workman JJ (2004) Anal Chem 76(12):3365–3372
Harre M, Tilstam U, Weinmann H (1999) Org Process Res Dev 3(5):304–318
Hinz DC (2004) PAT—J Process Anal Technol 1(2):16–18
Balboni ML (2003) Pharm Technol (North Am) 27(10):54–66, 254
Paulson W (ed) (2002) Gold Sheet 36(2):10
Lyon RC, Jefferson EH, Ellison CD, Buhse LF, Spencer JA, Nasr MM, Hussain AS (2003) Am Pharm Rev 6(3):62–70
DiMasi JA, Hansen RW, Grabowski HG (2003) J Health Econ 22:151–185
Pharmaceutical Research and Manufacturers of America (PhRMA) (2004). Pharmaceutical industry profile 2004. PhRMA, Washington, DC; http://www.phrma.org
Pelletier B (2004) Pharm Process 21(10):84–88
Wechsler J (2002) Pharm Technol North Am 26(2):16–24
Abboud L, Hensley S (2003) Factory shift—new prescription for drug makers: update the plants. Wall Street Journal , p 1, A6
Miller RW (2002) Am Pharm Rev 5(2):25–29
Miller RW (2003) Am Pharm Rev 6(1):52–61
Sherman RE (2005) The role of spectroscopy in process analytical technologies, supplement to spectroscopy, vol 20, no 1, pp 11–13
Koch MV, Marquardt BJ (2004) PAT—J Process Anal Technol 1(2):12–15
Paulson W (ed) (2003) Gold Sheet 37(6):10
U.S. Department of Health and Human Services, Food and Drug Administration (2004) Guidance for industry: PAT—a framework for innovative pharmaceutical development, manufacturing, and quality assurance. http://www.fda.gov/cder/guidance/6419fnl.pdf
Shanley A (2004) Pharm Manuf 6:41–45
Rubric News Spectrum (2005) Market profile—on-line spectroscopy and PAT. Spectroscopy 20(1):12
Bakeev KA (2003) Pharm Technol Eur 15(9):27–32
Afnan AM (2004) PAT—J Process Anal Technol 1 (1):8–9
Paulson W (ed) (2003) Gold Sheet 37(6):5
Cini P, Schneider RE (2004) Pharm Exec 24(3):86–95
Paulson B (ed) (2004) Gold Sheet 38(6):1–23
Gaffner C (2004) Medical Products Agency, Uppsala, Sweden, presentation. Regulatory milestones in EU with respect to PAT, presentation given at a training course for EU inspectors and quality assessors organised by the Swedish Medical Products Agency in collaboration with EMEA in September 2004; http://www.emea.eu.int/Inspections/docs/PAT%20Uppsala%20040923.pdf
Paulson B (ed) (2004) Gold Sheet 38(7):1–19
http://www.astm.org/cgi-bin/SoftCart.exe/COMMIT/COMMITTEE/E55. htm?L+mystore+ofnn3447
Paulson W (ed) (2003) Gold Sheet 37(6):7
Fischer G (2005) Sanofi-Aventis, Kansas City, MO. Experiences from a PAT pilot project, presentation at the 19th international forum process analytical technology (Process Analysis& Control)—IFPAC 2005; January 10–13, 2005, Arlington, Virginia (Washington, DC)
Paulson B (ed) (2004) Gold Sheet 38(11):7
D’Sa AM (2005) Office of Compliance, DMPQ CDER, FDA. Process analytical technology (PAT): regulatory process, review and inspection; presentation at the 19th international forum process analytical technology (Process Analysis& Control)—IFPAC 2005; January 10–13, 2005, Arlington, Virginia (Washington, DC)
Paulson B (ed) (2004) Gold Sheet 38(10):15
Radspinner D (2005) Sanofi-Aventis, Kansas City, MO. Implementing PAT—industry example, presentation at the 19th international forum process analytical technology (Process Analysis& Control)—IFPAC 2005; January 10–13, 2005, Arlington, Virginia (Washington, DC)
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Hinz, D.C. Process analytical technologies in the pharmaceutical industry: the FDA’s PAT initiative. Anal Bioanal Chem 384, 1036–1042 (2006). https://doi.org/10.1007/s00216-005-3394-y
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DOI: https://doi.org/10.1007/s00216-005-3394-y