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Other

First published 1993-1

Experiences with the Multi-State Procedure: Generics and New Chemical Entities

Mohamed Baccouche

Therapeutic Innovation & Regulatory Science

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Review article

First published 2022-04

Radioiodine Labeling Reagents and Methods for New Chemical Entities and Biomolecules

Krishan Kumar

Cancer Biotherapy and Radiopharmaceuticals

Free access

Research article

First published 2013-2

A Rapid Screening for Cytochrome P450 Catalysis on New Chemical Entities

Georgia E. Tsotsou, Giovanna Di Nardo, Sheila J. Sadeghi [...]

Journal of Biomolecular Screening

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Other

First published 1993-1

Registering A List B New Chemical Entity via the Concertation Procedure: A Case History

Sue Barrowcliffe

Therapeutic Innovation & Regulatory Science

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Research article

First published 2004-7

Generics Companies: Aspiring to Innovate

Faiz Kermani

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Other

First published 2004-1

The Regulation and Approval of New Drugs in China

Rongling Deng, Kenneth I Kaitin

Therapeutic Innovation & Regulatory Science

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Research article

First published 1996-1

Innovation Deficit in the Pharmaceutical Industry

Jürgen Drews, Stefan Ryser

Therapeutic Innovation & Regulatory Science

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Research article

First published 2018-9

Analysis of the Risks and Benefits of New Chemical Entities Approved by the US Food and Drug Administration (FDA) and Subsequently Withdrawn From the US Market

Peter A. Patriarca, R. Michael Van Auken, Scott A. Kebschull

Therapeutic Innovation & Regulatory Science

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Research article

First published 1991-4

A Module System for the Preparation of International Dossiers,Manufacturing,and Controls (New Chemical Entities)

Harvey Gurien

Therapeutic Innovation & Regulatory Science

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Research article

First published 1989-7

Core Requirements for International Registration of Drugs (New Chemical Entities): Manufacturing and Controls

Harvey Gurien, Gary M. Klee

Therapeutic Innovation & Regulatory Science

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