How Long to Read TEXTBOOK ON PHARMACEUTICAL REGULATORY AFFAIRS

How Long Does it Take to Read TEXTBOOK ON PHARMACEUTICAL REGULATORY AFFAIRS?

It takes the average reader 7 hours and 35 minutes to read TEXTBOOK ON PHARMACEUTICAL REGULATORY AFFAIRS by Dr. S. Valarmathi, Dr. Anasuya Patil, Dr. Abhishek Suman, Mr Vinay Kumar Yanmandru, Dr. NARLA SUNITHA, Prof. (Dr.) Varsha Deva

Assuming a reading speed of 250 words per minute. Learn more

Description

This book structured in TWO different parts. These parts are as follows: Part I emphasizes on GCP (Good Clinical Practices), GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), USFDA-NDA/ANDA (U S Food and Drug Administrations- New Drug Approval/Abbreviated New Drug Approval) and TQM (Total Quality Management). GCP (Good Clinical Practices) is an international quality standard that is provided by International Conference on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. Good Clinical Practice guidelines include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. Good Clinical Practice Guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry monitors are often called Clinical Research Associates. GLP (Good Laboratory Practices) deals with the organization, process and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. GLP practices are intended to promote the quality and validity of test data. Published GLP regulations and guidelines have a significant impact on the daily operation of an analytical laboratory. GMP (Good Manufacturing Practices) Manufacturing relies on the ability to reproduce exactly a single product hundreds, if not thousands, of times. To make this possible, guidelines have been drawn up in most countries that are similar to the FDA ones described here that define GMPs. Diagnostic companies, including those manufacturing and distributing biosensors, cannot sell their products for either public or professional use unless they have been approved on the basis of these guidelines. USFDA-NDA/ANDA (U S Food and Drug Ad

How long is TEXTBOOK ON PHARMACEUTICAL REGULATORY AFFAIRS?

TEXTBOOK ON PHARMACEUTICAL REGULATORY AFFAIRS by Dr. S. Valarmathi, Dr. Anasuya Patil, Dr. Abhishek Suman, Mr Vinay Kumar Yanmandru, Dr. NARLA SUNITHA, Prof. (Dr.) Varsha Deva is 452 pages long, and a total of 113,904 words.

This makes it 153% the length of the average book. It also has 139% more words than the average book.

How Long Does it Take to Read TEXTBOOK ON PHARMACEUTICAL REGULATORY AFFAIRS Aloud?

The average oral reading speed is 183 words per minute. This means it takes 10 hours and 22 minutes to read TEXTBOOK ON PHARMACEUTICAL REGULATORY AFFAIRS aloud.

What Reading Level is TEXTBOOK ON PHARMACEUTICAL REGULATORY AFFAIRS?

TEXTBOOK ON PHARMACEUTICAL REGULATORY AFFAIRS is suitable for students ages 12 and up.

Note that there may be other factors that effect this rating besides length that are not factored in on this page. This may include things like complex language or sensitive topics not suitable for students of certain ages.

When deciding what to show young students always use your best judgement and consult a professional.

Where Can I Buy TEXTBOOK ON PHARMACEUTICAL REGULATORY AFFAIRS?

TEXTBOOK ON PHARMACEUTICAL REGULATORY AFFAIRS by Dr. S. Valarmathi, Dr. Anasuya Patil, Dr. Abhishek Suman, Mr Vinay Kumar Yanmandru, Dr. NARLA SUNITHA, Prof. (Dr.) Varsha Deva is sold by several retailers and bookshops. However, Read Time works with Amazon to provide an easier way to purchase books.

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