The document summarizes the history and development of drug regulation laws in the United States from the early 1900s to present day. Key acts and amendments established safety testing requirements for drugs, created the FDA, and defined the modern drug approval process including preclinical research and multi-phase clinical trials. The modern system aims to balance drug accessibility while ensuring safety and efficacy through a rigorous review and oversight process from development through post-marketing.
Drug discovery and development is and always has been the most exciting part of clinical pharmacology. It is my attempt to compile the basic concepts from various books, articles and online journals. Feel free to comment.
Drug discovery and development is and always has been the most exciting part of clinical pharmacology. It is my attempt to compile the basic concepts from various books, articles and online journals. Feel free to comment.
Requirements And Guidelines For Permission To Import / or Manufacture of New Drugs For Sale or To Undertake Clinical Trials
Schedule Y was introduced under the Drugs and Cosmetics Act 1940, to
introduce requirements for countries to get permission for:
Importing
Manufacturing new drugs
Conducting Clinical Trials.
Application for permission
Clinical Trial
Studies in specific population
Post marketing surveillance
Special studies: BA/BE studies
This slide show reflects general considerations of Bio-availability & Bio-equivalence studies for orally administered drugs. The presentation also accommodates US - FDA's approach and specific recommendations for such studies.
Regulations for drug approval in USA, E.U & India
Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million.
Requirements And Guidelines For Permission To Import / or Manufacture of New Drugs For Sale or To Undertake Clinical Trials
Schedule Y was introduced under the Drugs and Cosmetics Act 1940, to
introduce requirements for countries to get permission for:
Importing
Manufacturing new drugs
Conducting Clinical Trials.
Application for permission
Clinical Trial
Studies in specific population
Post marketing surveillance
Special studies: BA/BE studies
This slide show reflects general considerations of Bio-availability & Bio-equivalence studies for orally administered drugs. The presentation also accommodates US - FDA's approach and specific recommendations for such studies.
Regulations for drug approval in USA, E.U & India
Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million.
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Introduction to Grey literature for Health SciencesFranklin Sayre
Slides for a short (1 hour 20 minute) workshop for graduate and post-graduate health science students and researchers on searching for grey literature.
This SlideShare gives an overview on how a drug is discovered, researched, developed, tested and reviewed for approval. It follows the current standard of approval set by the Food and Drug Administration (FDA), a federal agency of the United States Department of Health and Human Services. The process is generally divided into 4 Stages: Pre-Clinical, Clinical, New Drug Application (NDA) Review & Post-Marketing.
IND (Investigational New Drug) industrial perspectiveAYESHA NAZEER
Describing the Industry's/sponsor's/drug manufacturers' perspective of the Investigational New Drug Application (IND) program based on the survey conducted by the Office Of Inspector General (OIG).
A regulatory strategy is critical to the commercialization of biomedical technologies. In particular, technologies such as new drugs and medical devices have more regulatory needs, and the strategy should be considered simultaneous to a commercialization pathway.
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