'Investigational new drug' presentation slideshows

Human Gene Therapy: Risk Assessment and Regulatory Requirements

Human Gene Therapy: Risk Assessment and Regulatory Requirements. And Overview of the NIH rDNA Guidelines EMD 545b Lecture #10. NIH Guidelines for Research Involving rDNA Molecules (April, 2002). NIH Guidelines - April 2002. NIH - OBA (Office of Biotechnology Activities)

749 views • 60 slides

Introduction to Regulatory Statistical Principles

Introduction to Regulatory Statistical Principles. Peter A. Lachenbruch Oregon State University College of Public Health and Human Sciences (Ret.). Conclusion.

648 views • 51 slides

The Regulation of Drug and Biological Products Introduction to the Principles and Practice of Clinical Research

100 years. The Regulation of Drug and Biological Products Introduction to the Principles and Practice of Clinical Research. 250 years. Kathryn C. Zoon, Ph.D Acting Director DIR/NIAID January 2006. WHERE IS THE FDA? DHHS. Food and Drug Administration 2006. Acting Commissioner:

720 views • 49 slides

685 views • 48 slides

The Regulation of Drug and Biological Products Introduction to the Principles and Practice of Clinical Research

The Regulation of Drug and Biological Products Introduction to the Principles and Practice of Clinical Research. Kathryn C. Zoon, Ph.D Deputy Director Planning and Development DIR/NIAID January 11, 2005. Food and Drug Administration. Office of the Commissioner

753 views • 45 slides

Fecal Microbiota for Transplantation

Fecal Microbiota for Transplantation. Jay E. Slater, MD FDA/CBER/OVRR/DBPAP. Outline. Why does FDA regulate fecal microbiota for transplantation? When is an IND application required? What is included in an IND application? FMT research needs, and how FDA can help achieve them.

1.18k views • 30 slides

381 views • 25 slides

FDA IND Review: Regulations and Challenges

FDA IND Review: Regulations and Challenges. Wilson W. Bryan, M.D. FDA / CBER / OCTGT wilson.bryan@fda.hhs.gov Workshop on Cell and Gene Therapy Clinical Trials in Pediatric Populations North Bethesda, Maryland November 2, 2010.

855 views • 24 slides

APPLYING PRE-CLINICAL DATA TO CLINICAL STUDIES-I

APPLYING PRE-CLINICAL DATA TO CLINICAL STUDIES-I. Edward A. Sausville, M.D., Ph.D. Developmental Therapeutics Program National Cancer Institute October 17, 2002. GOALS OF PRECLINICAL DRUG STUDIES. Regulatory framework.

520 views • 23 slides

What Physiologists Working in Industry Do

What Physiologists Working in Industry Do. Physiologists in Industry Committee (PIC) American Physiological Society. Objective.

325 views • 23 slides

Pharmacology for the Health Sciences

Pharmacology for the Health Sciences. Lecture 3. How are Drugs Named?. Chemical Name Specifies chemical structure Pre patent or release name Typically drug company letters and numbers Generic Name Nonproprietary name (each drug has only one generic name) Brand or Trade Name

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Laboratory of Methods Development and Quality Control

436 views • 15 slides

Entrepreneurship in Biotechnology

Entrepreneurship in Biotechnology. Columbia University Graduate School of Arts and Sciences BIOT 4180. Week 10. Product Development: Clinical Development. Development Process. Decrease in productivity. Academia and Private Sector. Risk mitigation. Process. Phase 1: safety

349 views • 15 slides

DRUG PRODUCT DEVELOPMENT

DRUG PRODUCT DEVELOPMENT. Drug agent intended for use in the diagnosis, mitigation, treatment, cure, or prevention of disease in man or animals New Drug defined in section C.0 1A.001(2) of Food and Drug Regulations (HPFB)

287 views • 12 slides

DRUG PRODUCT DEVELOPMENT

DRUG PRODUCT DEVELOPMENT. Drug agent intended for use in the diagnosis, mitigation, treatment, cure, or prevention of disease in man or animals New Drug defined in section C.0 1A.001(2) of Food and Drug Regulations (HPFB)

448 views • 12 slides

Nanotechnology and cancer

Nanotechnology and cancer. Maria Guirguis Dr. Sun Biomedical Engineering Seminar 1. What is cancer?. Cancer is t he disease caused by an uncontrolled division of abnormal cells in a part of the body. Chemotherapy is the treatment that comes to mind right away. Nanotechnology.

1.43k views • 11 slides

IND Determinations

IND Determinations. An IRB Infoshort August 2013. IND. An Investigational New Drug is a drug that has not yet been approved by the FDA for marketing and is available only for use in research to determine safety and effectiveness.

302 views • 10 slides