Practical Issues of Preclinical Pharmacokinetic Investigations of New Drugs (Review)

Author:

Chistyakov V. V.,Stepanova E. S.

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmacology

Reference60 articles.

1. V. N. Solov’ev, A. A. Firsov, and V. A. Filov, Pharmacokinetics (Guide) [in Russian], Meditsina, Moscow, 1980.

2. Ministry of Health of the RF, Order No. 490n dated July 12, 2017, “On approval of the procedure for the formation of the registration dossier of drugs and requirements to documents in its structure, requirements for the volume of information provided in the drug registration dossier, for certain types of drugs for medical use and the order of submission of documents, from which the registration dossier of a drug is formed with the purposes of its state registration,” Section 5, Moscow, 2017.

3. Federal Law No. 61-FZ dated Apr. 12, 2010, “On circulation of medicines,” Art. 11, Moscow, 2010.

4. GOST 33044-2014. International Standard “Principles of Good Laboratory Practice.”

5. Ministry of Health of the RF, Order No. 199n dated Apr. 1, 2016, “On approval of good laboratory practice rules,” Moscow, 2016.

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