This paper summarizes and draws up the decision tree for the in vitro consistency evaluation of oral solid generic drugs in combination with the relevant technical requirements such as “Requirements for Application Materials for Consistency Evaluation of the Quality and Efficacy of Oral Solid Preparations of Chemical Generic Drugs (Trial)”, and discusses the in vitro […]

In this article we will be dealing with Key Equipment And Technology For The Production Of Oral Solid Dosage Forms Batching Equipment   1.Automatic Batching Weighing System   Ingredients are an indispensable key link in the production of many solid dosage forms, and the accuracy of ingredients has an important impact on the quality of

01 Drug Development Process, Chemical Characterization, Production And Control In Oral Solid Dosage Forms   Components in the formulation BE information 02 Chemical Characterization, Production And Control In Oral Solid Dosage Forms   Reverse Engineering incluation of three different lots of RLD for:   Potency/purity   Impurity profile (related substances)   Content uniformity   Weight variation   Dissolution profile   Disintegration time