Idea to Product: The Process
Nancy J. Alexander, Anne C. Wentz
Springer Science & Business Media, Sep 27, 1996 - Medical - 200 pages
The young investigator with an idea has to negotiate many institutional, federal, and industrial challenges in order to get a product to market. Nowhere is described the steps in the development of new drugs, diagnos tics, or devices; the person with an idea has nowhere to turn for information and details. The young investigator may understand the elements of basic and clinical research, but ordinarily has no insight into novel ways of finding research funding or how to explore to find the funding opportunities that are available. The young investigator has little knowledge of the mecha nisms to bring an idea through the developmental phases to the market. There are other players in this complex endeavor with whom he or she has no contact, including those from industry, the Food and Drug Administration, and the legal community. Exposure to the philosophy of product develop ment and to procedural information would be useful to the scientific com munity, as would contact with those who have successfully taken an idea to a finished product. A first attempt to do this was the symposium on Idea to Product: The Process, sponsored by Serono Symposia USA and held No vember 17 to 20, 1994, in Washington, D.C. This book comprises the pro ceedings of that meeting. The editors are indebted to the many contributors to this volume, and we are especially grateful to Serono Symposia USA and to Leslie Nies and her staff for their expertise in organizing the symposium.
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The Preclinical Research Process
The Commercial Development Process
Whats Involved in Clinical Research?
Product Development Partnership Role of Academia and the NIH
Identifying Funding Opportunities at the NIH A Grants Perspective
Identifying Funding Opportunities at the NIH A Contract Perspective
Role of the Institution in Furthering the Young Investigator
Role of Toxicology in Drug Discovery and Development
Patenting and Licensing An Overview of the Processes
Pharmaceutical Clinical Development
FDA Recommendations for Drug Safety Testing
Decision Strategies in Assessment of Reproductive and Developmental Toxicology A Paradigm for Safety Evaluation
What Is Involved in a New Drug Application?
Institutional Review Boards and Informed Consent
Postmarketing Surveillance A Brief Synopsis of Its History and Current Direction
I Had an Idea and I Made it Work Heres How
Formulation of Dosage Forms
Polymeric Drug Delivery Systems
What Is a Drug a Device a Biological?
Understanding the Organization and Function of the FDA
How to Apply for an IND
What Is a 510k and a PMA?
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academic adverse events agreements animals approval assessment BCNU bioavailability bioerodible biological biomedical biotechnology CDRH clinical development clinical investigation clinical research clinical studies clinical trials commercial conduct contract delivery systems determine developmental toxicity DHHS disease dosage form dose drug application drug product endpoints ethylene-vinyl acetate evaluation expedited review faculty Federal Food and Drug funding grants Health human subjects identify industry informed consent initial institutional review board institutions intended investigational new drug investigator's brochure involved labeling laboratory Langer licensing manufacturing marketing ment molecular molecules OPRR patients pharmaceutical pharmacokinetics pharmacology Phase polyanhydrides polymer population postmarketing surveillance potential preclinical predicate device premarket prior product development proposed protein protocol regulations regulatory reports reproductive risk safety and efficacy safety or effectiveness scientific scientists specific sponsor testing therapeutic tion toxicology volunteers