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8 April, 2022

ICH M4Q Common technical document for the registration of pharmaceuticals for human use – Introduction

This is one in a series of guidances that provides recommendations for applicants preparing theCommon Technical Document for the Registration of Pharmaceuticals for Human Use (CTD). […]
28 March, 2022

Comparator Management (P.2)

2. COMPARATOR DRUGS SOURCING PROCESS 2.3. Identification of the supply strategy to be used 2.3.1. Selection and communication of a comparator for a clinical trial The […]
22 March, 2022

Comparator Management (P.1)

A comparator drugs, also known as a reference drug, is one that is included in a clinical study for the purpose of making comparisons of its performance in a defined population.

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