CHANGE MANAGEMENT OF DRUG PRODUCTS REGISTRATION CONDITIONS: NEW ICH Q12 GUIDELINE

Guideline for the Development of Liposome Drug Products

3.1 Description and composition ....................................................................................... 4 3.2 Formulation development and characterization ........................................................... 4 3.2.1 Pharmaceutical development ............................................................................... 4 3.2.2 Characterization of drug products ............

2016 European guideline for the management of vulval conditions.

Vulval conditions may present to a variety of clinicians, such as dermatologists, gynaecologists and general practitioners. Women with these conditions are best managed by a multidisciplinary approach, which includes clear referral pathways between disciplines or access to a specialist multidisciplinary vulval service. Informed consent is a prerequisite for all examinations, investigations and ...

National guideline on the management of vulval conditions.

This guideline offers recommendation on the management of a range of vulval disorders which may present to genitourinary medicine (GUM) clinics. Vulval disorders represent a disparate group of conditions with a variety of causes, affecting a particular anatomical site and may affect women of any age. These guidelines concentrate on a selected group of conditions, whichmay bemanaged by genitouri...

2014 UK national guideline on the management of vulval conditions.

Scope and Purpose The main objective is to aid recognition of the signs and symptoms and complications of vulval conditions which may present in Genitourinary Medicine clinic attendees. This guideline offers recommendations on the diagnostic tests and treatment regimes needed for the effective management of the following vulval conditions: Vulval lichen sclerosus Vulval lichen planus Vulval der...

ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities), Step 3