FDA's Drug Review Process and the Package Label: Strategies for Writing Successful FDA Submissions - Image 1

£101.99

Academic Press FDA's Drug Review Process and the Package Label: Strategies for Writing Successful FDA Submissions

Name: FDA's Drug Review Process and the Package Label: Strategies for Writing Successful FDA Submissions
Brand: Academic Press
Price: 101.99 GBP
Availability: InStock

Pharmacy - Dispensing

This is the most expensive it has ever been. Walk away.

£102 today · previous high £102 · all-time low £96

NEW HERE?

Amazon shows you one price. We show you all of them.

Tosheroon watches Amazon prices so you don't have to. Every product on Amazon has a price history — we make it visible. Set the price you'd actually pay, and we'll email you the second it gets there. No app, no account, one email.

WHAT'S ON THIS PAGE

↓ Price chart
when this has been cheap or pricey

↓ Forecast
where the price is heading next

↓ Statistics
all-time high & low, recent range

↑ Price alert
name your number, we'll email you

Price History & Forecast

Grey patches = out of stock. Cheaper = lower on the chart. Hover for exact prices.

Last 628 days • 628 data points (No recent data available)

Historical

Generating forecast...

Price Distribution

Price distribution over 628 days • 6 price levels

Days at Price

Current Price

Price Analysis

Most common price: £99 (330 days, 52.5%)

Price range: £96 - £102

Price levels: 6 different prices over 628 days

Description

FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label. Reveals strategies for winning FDA approval and for drafting the package label Examples are from one hundred FDA-submissions (NDAs, BLAs) for one hundred different drugs, e.g., for oncology, metabolic diseases, autoimmune diseases, and neurological diseases This book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely, the data from NDAs and BLAs as published on FDA's website at the time FDA grants approval to the drug

Product Specifications

Brand: Academic Press
Format: Paperback
ASIN: 0128146478
Category: Books > Subjects > Health, Family & Lifestyle > Medical & Healthcare Practitioners > Allied Health Professions > Pharmacy - Dispensing
Domain: Amazon UK
Release Date: 05 December 2017
Listed Since: 02 August 2017

Barcode

No barcode data available

Academic Press FDA's Drug Review Process and the Package Label: Strategies for Writing Successful FDA Submissions

This is the most expensive it has ever been. Walk away.

Price History & Forecast

Price Distribution

Price Analysis

Description

Product Specifications

Barcode

Similar Products You Might Like

Theory of Drug Development (Chapman & Hall/CRC Biostatistics Series)

Medical Writing in Drug Development: A Practical Guide for Pharmaceutical Research

Theory of Drug Development: 61 (Chapman & Hall/CRC Biostatistics Series)

Global New Drug Development: An Introduction (ULLA Series in Pharmaceutical Sciences)

Fundamentals of Drug Development

Optimization of Pharmaceutical R&D Programs and Portfolios: Design and Investment Strategy

Drug Information: A Guide for Pharmacists, Fourth Edition

Guide to EU and UK Pharmaceutical Regulatory Law

Das europäische Arzneimittelrecht: Zentrale Rechtsfragen des Arzneimittelzulassungsverfahrens

Overcoming Obstacles in Drug Discovery and Development: Surmounting the Insurmountable―Case Studies for Critical Thinking

Artificial Intelligence for Drug Product Lifecycle Applications

Regulatory Affairs in the Pharmaceutical Industry

Comprehensive Medicinal Chemistry II, Volume 1: GLOBAL PERSPECTIVE

Case Studies in Modern Drug Discovery and Development

Combinatorial Synthesis of Natural Product-Based Libraries (Critical Reviews in Combinatorial Chemistry)

Statistical Issues in Drug Development (Statistics in Practice)

FDA Regulatory Affairs: Third Edition

Benefit-Risk Assessment in Pharmaceutical Research and Development (Chapman & Hall/CRC Biostatistics Series)

Specification of Drug Substances and Products: Development and Validation of Analytical Methods

Pharmazeutische/Medizinische Chemie: Arzneistoffe - von der Struktur zur Wirkung

Boosting Pharmaceutical Innovation in the Post-TRIPS Era: Real-Life Lessons for the Developing World

Pharmaceutical Product Development: Insights Into Pharmaceutical Processes, Management and Regulatory Affairs

Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition: 129 (Drugs and the Pharmaceutical Sciences)

Edward Elgar - Intellectual Property, Pharmaceuticals and Public Health