25
location. Second is providing new ways to grow and repair body tissues. The third is
using the detection of single molecules in diagnosis.
These new discoveries will present many exciting challenges for regulatory profes-
sionals. Understanding how drugs work at the molecular level, genetic variations, gene
sequences, gene therapy, biomarkers, proteomics, pharmacogenomics, the role of enzyme
systems in drug metabolism and now, nanotechnology, have added new material to the
curriculum at schools of medicine, nursing and pharmacy and to continuing education
programs.
To become conversant with pharmacodynamics and pharmacokinetics for newly
marketed combination drugs and devices and those on the horizon, regulatory profession-
als will need basic knowledge about physics, chemistry, biochemistry, genetics, molecular
biology, material science, bioinformatics and engineering. Any of this information related
to the new delivery system or compound must be compiled, understood and lucidly
explained verbally or in writing to agency reviewers prior to gaining premarket approval.
For combination drug-device or biologic-device products, this means understanding
the responsibilities for each product element and its manufacturer in terms of who the
primary reviewer will be, the submission format, mechanisms of action, cross-labeling,
effects on shelf life, biocompatibility, design assurance, risk management, adverse event
reporting (e.g., is the event due to the drug or to the device?), reimbursement, clinical trial
design and the quality system regulations for medical devices together with current Good
Manufacturing Practices for drugs and biologicals. (Combination products are unique
because manufacturers must meet two sets of quality system requirements.18) All of these
issues, and any others, should be discussed between the collaborating companies to facili-
tate the approval process.
References
1. Cancer Facts, National Cancer Institute, http://www.cancer.gov/aboutnci/cis Accessed 24 January 2012.
2. Sontra Medical Corporation website. www.sontra.com/technology/skinpermeation
3. Alivisatos AP. Less is more in medicine, Understanding Nanotechnology, Warner Books, New York, 2002, pp
56-69.
4. Freitas RA. Nanomedicine Vol. I: Basic Capabilities—a Review. Landes Bioscience Georgetown, TX, 1999.
5. Ratner M and Ratner D. Nanotechnology, Prentice Hall, Upper Saddle River, NJ, 2003.
6. Ibid.
7. Op cit 3.
8. Op cit 5.
9. Sinha PM, et al. “Nanoengineered device for drug delivery application.” Nanotechnology 15:S585-589, 2004.
10. Ibid.
11. Breimer DD. “Future challenges for drug delivery.” J Controlled Release 62:3-6, 1999.
12. NIH News, National Institutes of Health, Monday 13 September 2004.
13. Op cit 3
14. www.nanosphere.us/. Accessed 24 January 2012.
15. Kotulak R. Tiny battlefield in the war on disease. Chicago Tribune, 14 September 2004.
16. Weiss R. Nanomedicine’s promise is anything but tiny. Washington Post, 30 January 2005.
17. Delamothe T. “Nanotechnology: small science, big deal.” British Medical Journal 330:544, 2005.
18. 0Triolo P. “Coated combination products: regulation and technology.” MDDI 27(3):98-108, 2005.
This article is based on a similar one published in US Pharmacist, December 2004.
Published in Regulatory Affairs Focus, August 2005. Copyright © 2005 Regulatory Affairs Professionals Society.
Nanotechnology
location. Second is providing new ways to grow and repair body tissues. The third is
using the detection of single molecules in diagnosis.
These new discoveries will present many exciting challenges for regulatory profes-
sionals. Understanding how drugs work at the molecular level, genetic variations, gene
sequences, gene therapy, biomarkers, proteomics, pharmacogenomics, the role of enzyme
systems in drug metabolism and now, nanotechnology, have added new material to the
curriculum at schools of medicine, nursing and pharmacy and to continuing education
programs.
To become conversant with pharmacodynamics and pharmacokinetics for newly
marketed combination drugs and devices and those on the horizon, regulatory profession-
als will need basic knowledge about physics, chemistry, biochemistry, genetics, molecular
biology, material science, bioinformatics and engineering. Any of this information related
to the new delivery system or compound must be compiled, understood and lucidly
explained verbally or in writing to agency reviewers prior to gaining premarket approval.
For combination drug-device or biologic-device products, this means understanding
the responsibilities for each product element and its manufacturer in terms of who the
primary reviewer will be, the submission format, mechanisms of action, cross-labeling,
effects on shelf life, biocompatibility, design assurance, risk management, adverse event
reporting (e.g., is the event due to the drug or to the device?), reimbursement, clinical trial
design and the quality system regulations for medical devices together with current Good
Manufacturing Practices for drugs and biologicals. (Combination products are unique
because manufacturers must meet two sets of quality system requirements.18) All of these
issues, and any others, should be discussed between the collaborating companies to facili-
tate the approval process.
References
1. Cancer Facts, National Cancer Institute, http://www.cancer.gov/aboutnci/cis Accessed 24 January 2012.
2. Sontra Medical Corporation website. www.sontra.com/technology/skinpermeation
3. Alivisatos AP. Less is more in medicine, Understanding Nanotechnology, Warner Books, New York, 2002, pp
56-69.
4. Freitas RA. Nanomedicine Vol. I: Basic Capabilities—a Review. Landes Bioscience Georgetown, TX, 1999.
5. Ratner M and Ratner D. Nanotechnology, Prentice Hall, Upper Saddle River, NJ, 2003.
6. Ibid.
7. Op cit 3.
8. Op cit 5.
9. Sinha PM, et al. “Nanoengineered device for drug delivery application.” Nanotechnology 15:S585-589, 2004.
10. Ibid.
11. Breimer DD. “Future challenges for drug delivery.” J Controlled Release 62:3-6, 1999.
12. NIH News, National Institutes of Health, Monday 13 September 2004.
13. Op cit 3
14. www.nanosphere.us/. Accessed 24 January 2012.
15. Kotulak R. Tiny battlefield in the war on disease. Chicago Tribune, 14 September 2004.
16. Weiss R. Nanomedicine’s promise is anything but tiny. Washington Post, 30 January 2005.
17. Delamothe T. “Nanotechnology: small science, big deal.” British Medical Journal 330:544, 2005.
18. 0Triolo P. “Coated combination products: regulation and technology.” MDDI 27(3):98-108, 2005.
This article is based on a similar one published in US Pharmacist, December 2004.
Published in Regulatory Affairs Focus, August 2005. Copyright © 2005 Regulatory Affairs Professionals Society.
Nanotechnology