The role of the fDA in cancer clinical trials.

نویسنده

  • Steven Hirschfeld
چکیده

This chapter is intended to assist the clinical investigator in developing products, with an emphasis on biological cellular and gene therapy products, due to their complexity, that may be used for cancer therapeutics. It is not intended as a guide for general product development or general clinical trial design and analysis nor as a guide to protective vaccine development, drugs, or devices except as those products have overlapping regulations and procedures.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

A Review of Pomegranate Functional Compounds and Their Role in Human Health in Laboratory and Clinical Trials

Pomegranate as a functional food and nutraceutical source has gained widespread popularity. Pomegranate and its juice and extracts are currently being widely offered, with or without scientific support, to consumers as a new superfood with numerous health promoting effects. Therefore, due to the explosion of interest in pomegranate as a therapeutic source, the aim of the present work was to inv...

متن کامل

Marine Biotechnology and its potentials in cancer treatment: Review article

Marine environment has unique diversity. More than half of biodiversity lives at sea and oceans. Promotion of science and technology led to the future accession to marine species and study them and finally using marine product in human life. Using marine product for treatment of human malady is one of the most attractive applications of this component. Since cancer is the second mortality agent...

متن کامل

Systemic Targeted Alpha Radiotherapy for Cancer

Background: The fundamental principles of internal targeted alpha therapy for cancer were established many decades ago.The high linear energy transfer (LET) of alpha radiation to the targeted cancer cellscauses double strand breaks in DNA. At the same time, the short range radiation spares adjacent normal tissues. This targeted approach complements conventional external beam radiotherapy and ch...

متن کامل

A review on the role of oral ginseng on erection dysfunction and fatigue in prostate cancer patients

Background: Current pharmacological and non-pharmacological   treatment strategies   for   prostate cancer may control disease progression and increase the survival rates of patients but decreased quality of life is the most important concern of existing medical interventions. Erection dysfunction and fatigue are the most prevalent adverse effects of therapeutic procedures which impair the qual...

متن کامل

Evidence Based Medicine and Herbal Medicine

  Evidence based medicine (EBM) can be found as far back as the 1940s. However, it was in 1972 that the concept first came into play, originated by Professor Archie Cochrane, in his book, Effectiveness & Efficiency: Random Reflections on Health Services. This was the foundation for evidence based research, and in 1992 a facility was funded by the UK government, with the aim of performing r...

متن کامل

Dendritic Cells and Their Role in Cancer Immunotherapy

Dendritic cells (DCs) are antigen presenting cells with unique capability to take up and process antigens in the peripheral blood and tissues. They subsequently migrate to draining lymph nodes where they present these antigens and stimulate naive T lympho-cytes. During their life cycle, DCs go through two maturation stages and are referred to as immature and mature cells, respectively. While im...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:
  • Cancer treatment and research

دوره 132  شماره 

صفحات  -

تاریخ انتشار 2007