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New Drug Approval Process, Fifth Edition

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New Drug Approval Process, Fifth...

New Drug Approval Process, Fifth Edition

Guarino, Richard A.

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The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.

Updated chapters include:

advances in international regulatory requirements, including ICH guidelines and harmonization
a step-by-step format for content, assembly, and strategic approach in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs
the latest regulatory requirements for expediting new drug approvals
strategies for effective communication and integration of pharmaceutical personnel in all aspects of new drug development

درجه (قاطیغوری(:

کال:

2009

خپرونه:

5

خپرندویه اداره:

CRC Press

ژبه:

english

صفحه:

552

ISBN 10:

1420088505

ISBN 13:

9781420088502

لړ (سلسله):

Drugs and the Pharmaceutical Sciences

فایل:

PDF, 4.18 MB

IPFS:

,

english, 2009

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ممکن تاسی علاقمند شی

Chandrahas Sahajwalla — New Drug Development: Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics (Drugs and the Pharmaceutical Sciences)

Richard A. Guarino, Richard Guarino — New Drug Approval Process, , Accelerating Global Registrations

Ira R. Berry — Introduction to the Pharmaceutical Regulatory Process

Daniel Lednicer — The Organic Chemistry of Drug Synthesis (Organic Chemistry Series of Drug Synthesis) (Volume 7)

Sandy Weinberg — Guidebook for Drug Regulatory Submissions

Shayne Cox Gad — drug discovery handbook

Donald Monkhouse, Charles F. Carney, Jim Clark, Peter — Drug Products for Clinical Trials, Second Edition (Drugs and the Pharmaceutical Sciences)

Andrew Signore, Terry Jacobs — Good Design Practices for GMP Pharmaceutical Facilities

Weinberg Sandy — Good Laboratory Practice Regulations, Fourth Edition (Drugs and the Pharmaceutical Sciences)

Jan A. Rosier, Mark A. Martens, Josse R. Thomas — Development and Registration of New Drugs: An Introduction

Andrew Teasdale (Editor), David Elder (Editor), Raymond W. Nims (Editor) — ICH Quality Guidelines: An Implementation Guide

Friedhoff, Lawrence Tim — New Drugs: An Insider's Guide to the FDA's New Drug Approval Process for Scientists, Investors and Patients

R. Berry Ira, Robert P. Martin — The Pharmaceutical Regulatory Process

Bolton Sanford, Charles Bon — Pharmaceutical Statistics: Practical and Clinical Applications, Fifth Edition (Drugs and the Pharmaceutical Sciences)

Mark Rogge, David R. Taft — Preclinical Drug Development, Second Edition (Drugs and the Pharmaceutical Sciences, Vol 187)

Richard A Guarino — New drug approval process

Stanley Nusim — Active Pharmaceutical Ingredients

John J. Tobin, Gary Walsh — Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

Giordanetto, Fabrizio — Early drug development : bringing a preclinical candidate to the clinic / Volume 1-2.

unknown — Basic Principles of Clinical Research and Methodology

Sumantra Ray, Sue Fitzpatrick, Rajna Golubic, Susan Fisher, Sarah Gibbings — Oxford Handbook of Clinical and Healthcare Research

Ray, Sumantra; Fitzpatrick, Sue; Golubic, Rajna — Oxford Handbook of Clinical and Healthcare Research

Rosenbaum D., Dresser M. — Clinical Research Coordinator Handbook: GCP Tools and Techniques

Richard Chin, Menghis Bairu — Global Clinical Trials: Effective Implementation and Management

Natasha Martien & Jeff Nelligan — The sourcebook for clinical research : a practical guide for study conduct

United States. Food and Drug Administration — Compact regs parts 50, 54, 56 and 312 : Code of federal regulations 21, parts 50, 54, 56 and 312, good clinical practices

Cato, Allen — Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition

Joy A. Cavagnaro (editor), Mary Ellen Cosenza (editor) — Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals

Nigel Dent (Author); Ramzan Visanji (Author) — Veterinary Clinical Trials From Concept to Completion

Evan B. Siegel — Development and Approval of Combination Products: A Regulatory Perspective

Lionel D. Edwards, Andrew J. Fletcher, Anthony W. Fox, Peter D. Stonier — Principles and Practice of Pharmaceutical Medicine

Mitchell N. Cayen — Early Drug Development: Strategies and Routes to First-in-Human Trials

Vera Mihajlovic-Madzarevic — Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections

Salah Abdel?Aleem(auth.) — Design, Execution, and Management of Medical Device Clinical Trials

William J Brock; Kenneth L Hastings — Nonclinical safety assessment : a guide to international pharmaceutical regulations

Andrew J. Fletcher, Lionel D. Edwards, Anthony W. Fox, Peter D. Stonier — Practice and Principles of Pharmaceutical Medicine

Richard A. Guarino — New Drug Approval Process

Cato — Clinical Drug Trials and Tribulations, Second Edition, (Drugs and the Pharmaceutical Sciences)

Richard A. Guarino — New Drug Approval Process Accelerating Global Registrations

Food and Drug Administration — Compact Regs Parts 50, 54, 56, and 312: CFR 21 Parts 50, 56, and 312 Good Clinical Practices (10 Pack)

Lionel D. Edwards, Anthony W. Fox, Peter D. Stonier — Principles and Practice of Pharmaceutical Medicine, Third Edition

Margaret B. Liu, Kate Davis(auth.) — A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons From A Horse Named Jim, Second Edition

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