Teachers have been compelled to conform to a ceaseless flow of directives, regulations and notes of guidance.
The safety evaluation of the SilEmulsion was conducted according to the SCCS's Notes of Guidance for Testing of Cosmetic Ingredients and their Safety Evaluation [ 25].
For cosmetic ingredients, the basics of risk characterisation are laid down in the SCCP's 'Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation', which has not yet been adapted for the risk assessment of NM.
The study is conducted in accordance with the Declaration of Helsinki, Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95 - annotated with TGA comments), NHMRC National Statement on Ethical Conduct in Human Research, NHMRC Australian Code for the Responsible Conduct of Research, and all applicable laws and regulations.
The CPMP Note for Guidance 'Evaluation of anticancer medicinal products in man' (CPMP/EWP/205/95 rev.2, 19 September 2002) presents guidelines on the requirements for authorisation for all anticancer drugs, particularly cytotoxic/cytostatic agents, and is intended to assist applicants in regular and exceptional circumstances (http://www.emea.eu.int/).
Another important issue related to the validation concept is the validation of analytical methods, whose general principles are outlined in ICH Q(2) R1 – Note for Guidance on validation of analytical procedures: text and methodology (ICH guideline), which define the type of analytical methods to be validated and set parameters of concern and acceptance criteria to be considered.
The study was conducted in full conformity with the principles of the Declaration of Helsinki, the EMEA Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95), and International Ethical Guidelines for Biomedical Research Involving Human Subjects Council for International Organizations of Medical Sciencess 2002).
Typical acceptance criteria is 10 Colony Forming Unit (CFU) / 100 ml (Note for guidance on manufacture of the finished dosage).
The EMA stated that "most of these medicines continue to outweigh their risks" and that controlling the release rate within a formulation makes pain management more effective ((1999) Note for guidance on quality of modified release products: a oral dosage forms, B: transdermal dosage forms section 1 (Quality), in, European Medicines Agency Committee for Proprietary Medicinal Products).
Also the recently modified EMEA note for guidance on the development of anticancer medicinal products, supported by other EMEA guidelines, gives clear instructions about the prerequisites and execution of early clinical trials with anticancer agents.
