There are no explicit provisions on the storage of test related documents. However, ichgcp stipulates the minimum filing documents - basic documents.

Now the new regulation stresses that the old version of the test documents should be kept and indicated with expiration date.

Upon trial completion, the supervisor will retrieve the original case report form's first page, followed by data entry into the database for statistical analysis by the biostatistician per the pre-trial plan.

According to the tenets of the declaration of Helsinki, subjects can withdraw from the trial at any time according to their own wishes without any reason.

To safeguard participant privacy in the clinical trial, only initials—rather than full names—should be used in trial documents, particularly those submitted to the sponsor.

When submitting an ANDA, generic drug manufacturers need to submit one of the following four statements in accordance with the provisions of the Orange Book.

It depends on what type of exclusivity is at issue.

The combination of dietary supplements and drugs should be approached with caution, as interactions between them can affect the efficacy and safety of both substances.

Biologic exclusivity conveys 12 years of total market protection.

Drug delivery can be significantly affected by the pH of the environment in which it occurs.

The solubility of a drug can significantly impact its bioavailability, absorption rate, and ultimately, its effectiveness as a therapeutic agent.

To optimize drug dosage adjustments for individual patient profiles in the context of combination therapy, several factors should be considered.