The process of authorisation for SVHCs will achieve its full potential in promoting substitution of hazards when companies proactively change formulations and downstream users demand that suppliers avoid using SVHCs in their products.
Biowaivers During Scale-Up and Post-approval Changes: Certain formulation changes in components and composition, scale-up, manufacturing site change, manufacturing process, or equipment changes may be made post-approval.
Depending on the possible impact of the manufacturing change on the release of the active ingredient and its bioavailability from that formulation, certain manufacturing changes for IR products can be approved solely based on comparability of the dissolution profiles between the post-change and pre-change formulations.
Interventions based on a treatment simplification (TRT simpl ) consist of changes in the dosage schedule (e.g., once daily vs. twice daily) or a change in formulation (e.g., change from tablets to liquid formulation); Cognitive-educational interventions (Cogn-Educ ) present information individually or in a group setting, delivering it verbally, in written form, and/or audiovisually.
Another idea was to combine it with a different heartburn remedy, or to change the formulation, so that it came in a liquid gel or in an extended-release form.
Mr. Syrett: And even if we figured it out today, we wouldn't know tomorrow, because they could change their formulation.
April 17 2003 memo from Charlotte Reader, Reckitt marketing manager "If we were to change the formulation... with the rationale that we are doing so for health and safety reasons... we could withdraw Gaviscon liquid from sale within the NHS and replace it with the new formulation..
