Pharma Digests
FDA Non-Clinical Study Requirements for IND
Non-clinical studies are essential for assessing the safety and biological activity of an investigational drug before it is tested in humans. Here are the key aspects and requirements for non-clinical studies in an IND application: Pharmacology and Toxicology Information Non-clinical studies primarily focus on pharmacology and toxicology to evaluate the ... Read More
FDA Clinical Study Requirements for IND
Clinical study requirements for an Investigational New Drug (IND) application are designed to ensure the safety and efficacy of the investigational drug during human trials. Here are the key aspects and requirements: Clinical Study Protocol A detailed clinical study protocol must be included in the IND application. This protocol should ... Read More
Administrative Modules and Submission of IND Application
The administrative module of an IND application includes essential forms and information that provide the FDA with details about the sponsor, the investigational drug, and the proposed clinical trials. Key components include: Submission The submission of an IND application involves several steps to ensure that the FDA receives all necessary ... Read More
Types and Components of Investigational New Drugs (IND) Application
An Investigational New Drug (IND) application is a request for authorization from the FDA to administer an investigational drug or biological product to humans. This application must be authorized before the interstate shipment and administration of any new drug or biological product that is not the subject of an approved ... Read More
SOP for Change Control in Pharmaceutical Industry
1.0 OBJECTIVE To lay down a procedure for Change Control. 2.0 SCOPE The SOP is applicable to any change in the documentation and facility required to be carried out to make amendments, rectify errors, improvements, meet regulatory/ statutory/ legal requirements. It shall be applicable to all Departments at XYZ pharm. ... Read More
Foundational Principles of ICH GCP
Let’s delve into the fundamental principles that shape the ethical conduct of clinical trials according to ICH Good Clinical Practice (GCP): Ethical Foundation: Clinical trials must align with the ethical principles outlined in the Declaration of Helsinki, ensuring consistency with GCP and relevant regulatory requirements. Balancing Risks and Benefits: Before ... Read More
Diabetes and Foot Care Recommendations
American Diabetes Association (ADA) Standards of Care 2024: 1. Perform a comprehensive foot evaluation at least annually to identify risk factors for ulcers and amputations. 2. The examination should include inspection of the skin, assessment of foot deformities, neurological assessment (10-g monofilament testing with at least one other assessment: pinprick, ... Read More
Insulin Therapy in Type 2 Diabetes
ADA Standards of Care 2024 1. Many adults with type 2 diabetes eventually require and benefit from insulin therapy. The progressive nature of type 2 diabetes should be regularly and objectively explained to individuals with diabetes, and clinicians should avoid using insulin as a threat or describing it as a ... Read More
LYRICA (Pregabalin) | Drug Digest
LYRICA (pregabalin) has been Pfizerโs flagship blockbuster brand for many years due to the fact that it has been approved in multiple indications. It has also been the highest-selling neurology brand for several years. As such, the company has tried using aggressive strategies to extend the brandโs lifecycle in order ... Read More
ACCUTANE (Isotretinoin) | Drug Digest
ACCUTANE (isotretinoin) is indicated for the treatment of: Because of significant side effects associated with its use, ACCUTANE should be reserved for patients where the conditions listed above are unresponsive to conventional first line therapies. ACCUTANE should only be prescribed by physicians knowledgeable in the use of retinoids systemically, who ... Read More
Effective Design of Clinical Trials | FDA
The 1962 FD&C Act Prior to 1962, drug safety was the primary concern, but the act revolutionized the landscape by demanding substantial evidence of a drug’s effectiveness. This shift led to the requirement of “adequate and well-controlled studies” – a cornerstone of modern clinical research. ๐๐ฑ๐ฒ๐พ๐๐ฎ๐๐ฒ ๐ฎ๐ป๐ฑ ๐ช๐ฒ๐น๐น-๐๐ผ๐ป๐๐ฟ๐ผ๐น๐น๐ฒ๐ฑ ๐ฆ๐๐๐ฑ๐ถ๐ฒ๐: ๐ง๐ต๐ฒ ... Read More