A regulatory perspective of clinical trial applications for biological products with particular emphasis on Advanced Therapy Medicinal Products (ATMPs)

Author:

Jones David R.1,McBlane James W.1,McNaughton Graham1,Rajakumaraswamy Nishanthan1,Wydenbach Kirsty1

Affiliation:

1. Clinical Trials Unit; Medicines and Healthcare products Regulatory Agency (MHRA); London; UK

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference30 articles.

1. Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on Advanced Therapy Medicinal Products and Amending Directive 2001/83/EC and Regulation (EC) No 726/2004

2. Understanding and applying regulatory guidance on the nonclinical development of biotechnology-derived pharmaceuticals;Snodin;BioDrugs,2006

3. CHMP/SWP/1042/99 (R1) Guideline on Repeated Dose Toxicity

4. Safety evaluation to support first-in-man investigations: I: kinetic and safety pharmacology studies;Baldrick;Regul Toxicol Pharmacol,2008

5. Considerations in assessing the developmental and reproductive toxicity potential of biopharmaceuticals;Martin;Birth Defects Res B Dev Reprod Toxicol,2009

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