Introduction The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonization through the development ..
The following is a list of steps to place a B12 shot yourself. Wash hands and lay out what you will need. Lay down a paper towel for your workspace Place the following onto your paper towel: alcohol wipes or a cotton ball with alcohol, B12 prefilled injectable syringe, and the needle that comes in ..
The IB also provides insight to support the clinical management of the study subjects during the course of the clinical trial. The information should be presented in a concise, simple, objective, balanced, and non-promotional form that enables a clinician, or potential investigator, to understand it and make his/her own unbiased risk-benefit assessment of the appropriateness ..
Introduction to Scale-Up and Post-Approval Changes (SUPAC) Scale-up is an inevitable part of the product life cycle of every successful drug, and each time it is required, a meticulous process must be followed to ensure that the end result is identical to the product formulation as originally devised. American Association of Pharmaceutical Scientists (AAPS), the ..
Bracketing: The design of a stability schedule such that only samples on the extremes of certain design factors (e.g., strength and package size) are tested at all time points as in a full design. The design assumes that the stability of any intermediate levels is represented by the stability of the extremes tested. For example, ..
Other important postmarketing surveillance components include unapproved or off-label drug use, problems with orphan drugs, and lack of paediatric formulations, as well as issues concerning international clinical trials in paediatric population. The process of evaluating and improving the safety of medicines used in paediatric practice is referred to as paediatric pharmacovigilance. It requires special attention. ..
Definition: Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency of analytical results; it is an integral part of any good analytical practice. Analytical methods need to ..