Regulatory affairs in the pharmaceutical industry / edited by Javed Ali, Sanjula Baboota.

Format:

Book

Contributor:

Jāvīd, ʻAlī, editor.

Baboota, Sanjula, editor.

Edward Potts Cheyney Memorial Fund.

Language:

English

Subjects (All):

Drugs--Law and legislation.

Drugs.

Pharmacy--Law and legislation.

Pharmacy.

Pharmaceutical industry.

Pharmaceutical policy.

Physical Description:

xvi, 269 pages ; 28 cm

Place of Publication:

London, United Kingdom ; San Diego, CA : Academic Press, [2022]

Contents:

Machine generated contents note: 1.1. Introduction / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.1.1. Reason for the requirement of a drug regulatory department in the pharmaceutical industry / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.1.2. Responsibilities and duties of Drug Regulatory Affair professionals / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.1.3. Different regulatory agencies regulating pharmaceutical industries worldwide / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.2. Pharmaceutical regulatory affairs: documentation / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.2.1. Dossiers / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.2.2. Drug master file / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.2.3. Master formula record / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.2.4. Batch manufacturing formula record / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.2.5. Distribution record / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.3. Applications filed by the Drug Regulatory Affairs department / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.3.1. Investigational new drug application / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.3.2. New drug application / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.3.3. Abbreviated new drug application / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.4. Hatch-Waxman Act and amendments / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.4.1. Orange Book / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.4.2. Biologics license application / Harmanpreet Singh / Jasjeet Kaur Narang / Sanjula Baboota / Javed Ali / Anmol Dogra

1.4.3. Marketing Authorization Application / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.4.4. Scale-up, process approval changes, and postmarketing surveillance / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.4.5. Food and Drug Administration Modernization Act / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.4.6. Postmarketing surveillance / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.4.7. Good manufacturing practice certification / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.4.8. Application for getting a certificate of pharmaceutical product / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.4.9. Patent certifications / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.4.10. Trademark registration / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.4.11. Copyright registration / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.4.12. Design registration in pharmaceutical context / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

1.5. Conclusion / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

References / Jasjeet Kaur Narang / Anmol Dogra / Harmanpreet Singh / Sanjula Baboota / Javed Ali

2.1. Introduction / Shobhit Kumar / Sanjula Baboota / Javed Ali

2.2. Regulatory requirements and active pharmaceutical ingredients approval process / Shobhit Kumar / Sanjula Baboota / Javed Ali

2.2.1. Registration of active pharmaceutical ingredients / Shobhit Kumar / Sanjula Baboota / Javed Ali

2.2.2. Drug master file / Shobhit Kumar / Sanjula Baboota / Javed Ali

2.2.3. Recent changes in the drug master file rules / Shobhit Kumar / Sanjula Baboota / Javed Ali

2.2.4. Responsibilities of active pharmaceutical ingredients manufacturer / Shobhit Kumar / Sanjula Baboota / Javed Ali

2.2.5. Letter of access / Shobhit Kumar / Sanjula Baboota / Javed Ali

2.2.6. Regulatory requirement for drug approval in the United States / Shobhit Kumar / Javed Ali / Sanjula Baboota

2.3. Novel drugs and their regulatory requirements / Shobhit Kumar / Sanjula Baboota / Javed Ali

2.3.1. Rules for approval of novel drugs / Shobhit Kumar / Sanjula Baboota / Javed Ali

2.3.2. Approaches for approval / Shobhit Kumar / Sanjula Baboota / Javed Ali

2.3.3. CDSCO and rules for novel drug marketing / Shobhit Kumar / Sanjula Baboota / Javed Ali

2.4. Guidelines on approval of novel drug delivery systems / Shobhit Kumar / Sanjula Baboota / Javed Ali

2.5. Regulation for nanotechnology products / Shobhit Kumar / Sanjula Baboota / Javed Ali

2.5.1. FDA's methodology for various product classes / Shobhit Kumar / Sanjula Baboota / Javed Ali

2.5.2. Data required for nanopharmaceuticals evaluation / Shobhit Kumar / Sanjula Baboota / Javed Ali

2.6. Biologics and its regulatory guidelines / Shobhit Kumar / Sanjula Baboota / Javed Ali

2.6.1. International standards for regulation of biologics / Shobhit Kumar / Sanjula Baboota / Javed Ali

2.6.2. U.S. Food and Drug Administration biologics team / Shobhit Kumar / Sanjula Baboota / Javed Ali

2.6.3. Postlicensing monitoring / Shobhit Kumar / Sanjula Baboota / Javed Ali

2.7. Conclusion / Shobhit Kumar / Sanjula Baboota / Javed Ali

References / Shobhit Kumar / Sanjula Baboota / Javed Ali

3.1. Introduction / Abhijeet Ojha / Bhavna / Samir Bhargava

3.1.1. Opportunities and difficulties / Bhavna / Samir Bhargava / Abhijeet Ojha

3.1.2. History of ICH / Bhavna / Samir Bhargava / Abhijeet Ojha

3.1.3. Progression of ICH harmonization / Bhavna / Samir Bhargava / Abhijeet Ojha

3.2. Outlines of ICH guidelines / Bhavna / Samir Bhargava / Abhijeet Ojha

3.2.1. Quality guidelines / Bhavna / Samir Bhargava / Abhijeet Ojha

3.2.2. Safety guidelines / Bhavna / Samir Bhargava / Abhijeet Ojha

3.2.3. Efficacy guidelines / Bhavna / Samir Bhargava / Abhijeet Ojha

3.2.4. Multidisciplinary guidelines / Bhavna / Samir Bhargava / Abhijeet Ojha

3.3. Conclusion / Bhavna / Samir Bhargava / Abhijeet Ojha

References / Bhavna / Samir Bhargava / Abhijeet Ojha

4.1. Introduction / Sonal Gupta / Shweta Dang / Javed Ali / Sanjula Baboota

4.2. Chemistry, manufacturing, and controls submission at investigational new drug (IND) stage / Sonal Gupta / Shweta Dang / Javed Ali / Sanjula Baboota

4.3. Chemistry, manufacturing, and controls submission at new drug application (NDA) stage / Sonal Gupta / Shweta Dang / Javed Ali / Sanjula Baboota

4.4. CMC changes and maintaining the CMC regulatory compliance / Sonal Gupta / Shweta Dang / Javed Ali / Sanjula Baboota

4.5. Combination product regulations / Sonal Gupta / Shweta Dang / Javed Ali / Sanjula Baboota

4.5.1. Premarket review process / Sonal Gupta / Shweta Dang / Javed Ali / Sanjula Baboota

4.5.2. Marketing application / Sonal Gupta / Shweta Dang / Javed Ali / Sanjula Baboota

4.6. Medical devices regulations / Sonal Gupta / Shweta Dang / Javed Ali / Sanjula Baboota

4.7. Conclusion / Sonal Gupta / Shweta Dang / Javed Ali / Sanjula Baboota

References / Sonal Gupta / Shweta Dang / Javed Ali / Sanjula Baboota

5.1. Global submissions / Shrestha Sharma / Rajesh Sharma / Syed Arman Rabbani

5.1.1. Introduction / Shrestha Sharma / Rajesh Sharma / Syed Arman Rabbani

5.1.2. Drug approval in the United States / Shrestha Sharma

/ Rajesh Sharma / Syed Arman Rabbani

5.1.3. Drug approval in Europe and United Kingdom / Shrestha Sharma / Rajesh Sharma / Syed Arman Rabbani

5.1.4. Investigational medicinal product dossier / Syed Arman Rabbani / Shrestha Sharma / Rajesh Sharma

5.1.5. Drug approval process in Australia / Shrestha Sharma / Rajesh Sharma / Syed Arman Rabbani

5.1.6. Drug approval in Japan / Shrestha Sharma / Rajesh Sharma / Syed Arman Rabbani

5.1.7. Approval of new drug in India / Shrestha Sharma / Rajesh Sharma / Syed Arman Rabbani

5.2. Common technical document / Shrestha Sharma / Rajesh Sharma / Syed Arman Rabbani

5.2.1. Module 1: general information / Shrestha Sharma / Rajesh Sharma / Syed Arman Rabbani

5.2.2. Module 2: CTD summaries / Shrestha Sharma / Rajesh Sharma / Syed Arman Rabbani

5.2.3. Module 3: quality / Shrestha Sharma / Rajesh Sharma / Syed Arman Rabbani

5.2.4. Module 4: nonclinical study reports / Shrestha Sharma / Rajesh Sharma / Syed Arman Rabbani

5.2.5. Module 5: clinical study reports / Shrestha Sharma / Rajesh Sharma / Syed Arman Rabbani

5.3. Investigator's brochure / Shrestha Sharma / Rajesh Sharma / Syed Arman Rabbani

5.3.1. General considerations / Shrestha Sharma / Rajesh Sharma / Syed Arman Rabbani

5.3.2. Purpose of an Investigator's Brochure / Shrestha Sharma / Rajesh Sharma / Syed Arman Rabbani

Contents note continued: 5.3.3. Aims of an Investigator's Brochure / Shrestha Sharma / Rajesh Sharma / Syed Arman Rabbani

5.3.4. Revision of an Investigator's Brochure / Shrestha Sharma / Rajesh Sharma / Syed Arman Rabbani

5.3.5. Contents of Investigator's Brochure / Syed Arman Rabbani / Rajesh Sharma / Shrestha Sharma

5.3.6. Summary of data and guidance for the investigator / Shrestha Sharma / Rajesh Sharma / Syed Arman Rabbani

5.3.7. Regulation of Investigator's Brochure / Shrestha Sharma / Syed Arman Rabbani / Rajesh Sharma

5.4. Conclusion / Syed Arman Rabbani / Rajesh Sharma / Shrestha Sharma

References / Syed Arman Rabbani / Shrestha Sharma / Rajesh Sharma

6.1. Introduction / Sandesh Lodha / Hetal Patel / Shrikant Joshi / Gajanan Kalyankar / Ashish Mishra

6.2. Marketing authorization of pharmaceuticals in the EU / Sandesh Lodha / Hetal Patel / Shrikant Joshi / Gajanan Kalyankar / Ashish Mishra

6.2.1. Introduction / Shrikant Joshi / Hetal Patel / Sandesh Lodha / Gajanan Kalyankar / Ashish Mishra

6.2.2. Steps before submission of application (EMA/821278/2015) / Gajanan Kalyankar / Shrikant Joshi / Hetal Patel / Sandesh Lodha / Ashish Mishra

6.2.3. Submission of the application / Sandesh Lodha / Hetal Patel / Shrikant Joshi / Gajanan Kalyankar / Ashish Mishra

6.2.4. Evaluation of the application / Gajanan Kalyankar / Shrikant Joshi / Hetal Patel / Sandesh Lodha / Ashish Mishra

6.2.5. Decision on marketing approval / Hetal Patel / Sandesh Lodha / Shrikant Joshi / Gajanan Kalyankar / Ashish Mishra

6.2.6. Assigning new marketing approval number and product information requirements / Hetal Patel / Sandesh Lodha / Shrikant Joshi / Ashish Mishra / Gajanan Kalyankar

6.2.7. Withdrawal of MAA / Sandesh Lodha / Hetal Patel / Gajanan Kalyankar / Shrikant Joshi / Ashish Mishra

6.2.8. Marketing approval: biosimilar medicines / Sandesh Lodha / Hetal Patel / Shrikant Joshi / Gajanan Kalyankar / Ashish Mishra

6.2.9. Marketing approval: generic and hybrid applications / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.2.10. Marketing approval: pediatrics / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.2.11. Pediatric-use marketing authorizations / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.3. Marketing authorization of pharmaceuticals in the United Kingdom / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.3.1. Application process / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.3.2. Product license number / Shrikant Joshi / Gajanan Kalyankar / Hetal Patel / Sandesh Lodha / Ashish Mishra

6.3.3. Active substance master files / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.3.4. Summary of product characteristics / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.3.5. Providing a name for your medicine / Hetal Patel / Shrikant Joshi / Sandesh Lodha / Ashish Mishra / Gajanan Kalyankar

6.3.6. Fast track your marketing authorization / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.3.7. Payments / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.3.8. Rejection / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.4. Marketing authorization of pharmaceuticals in the United States / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.4.1. Introduction / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.4.2. Marketing of veterinary products in the United States / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.5. Marketing authorization process for Japan / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.5.1. New drug application / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.5.2. Generic drug approval process / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.5.3. Orphan drug regulation in Japan / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.5.4. Biological product approval in Japan / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.6. Marketing authorization for pharmaceuticals in Australia / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.6.1. Introduction / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.6.2. Application for registering drug product / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.6.3. Registration of over-the- counter (OTC) medicine / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.6.4. Registration of complementary medicine / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.7. Marketing authorization of pharmaceuticals in India / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.7.1. Introduction / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.7.2. Regulatory framework / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.7.3. Prohibition of importing and/or manufacturing of certain drugs or cosmetics / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.7.4. Import and manufacture of drugs for commercial use in India / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.7.5. Import and manufacturing of drugs for examination, testing, or analysis / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.7.6. Import or manufacture of novel homeopathic medicine / Ashish Mishra / Sandesh Lodha / Gajanan Kalyankar / Shrikant Joshi / Hetal Patel

6.7.7. Selling, stocking, exhibiting, offering for sale, or distributing drugs (including homeopathic) in India / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.7.8. Manufacturing Ayurvedic, Siddha, or Unani medicine / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.7.9. Cosmetics / Sandesh Lodha / Hetal Patel / Shrikant Joshi / Gajanan Kalyankar / Ashish Mishra

6.7.10. New drugs / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.7.11. Similar biologics / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.7.12. SUGAM portal / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

6.8. Conclusion / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

References / Sandesh Lodha / Hetal Patel / Ashish Mishra / Gajanan Kalyankar / Shrikant Joshi

7.1. Introduction / Suresh K. Mohankumar / G.N.K. Ganesh

7.2. Malaysia / Suresh K. Mohankumar / G.N.K. Ganesh

7.3. Indonesia / Suresh K. Mohankumar / G.N.K. Ganesh

7.4. Thailand / Suresh K. Mohankumar / G.N.K. Ganesh

7.5. Vietnam / Suresh K. Mohankumar / G.N.K. Ganesh

7.6. Philippine / Suresh K. Mohankumar / G.N.K. Ganesh

7.7. Myanmar / Suresh K. Mohankumar / G.N.K. Ganesh

7.8. Sudan / Suresh K. Mohankumar / G.N.K. Ganesh

7.9. Uganda / Suresh K. Mohankumar / G.N.K. Ganesh

7.10. Zimbabwe / Suresh K. Mohankumar / G.N.K. Ganesh

7.11. Conclusion / Suresh K. Mohankumar / G.N.K. Ganesh

Acknowledgment / G.N.K. Ganesh / Suresh K. Mohankumar

References / Suresh K. Mohankumar / G.N.K. Ganesh

8.1. Introduction / Gulam Mustafa / Md Ali Mujtaba / Sabna Kotta / Shadab Md / Nabil A.

Alhakamy / Hibah M. Aldawsari / Shahid Karim / Abdullah Habeeballah

8.2. In vitro drug product performance / Gulam Mustafa / Md Ali Mujtaba / Sabna Kotta / Shadab Md / Nabil A. Alhakamy / Hibah M. Aldawsari / Shahid Karim / Abdullah Habeeballah

8.3. In vitro drug product performance evaluation / Gulam Mustafa / Md Ali Mujtaba / Sabna Kotta / Shadab Md / Nabil A. Alhakamy / Hibah M. Aldawsari / Shahid Karim / Abdullah Habeeballah

8.3.1. Disintegration test / Gulam Mustafa / Md Ali Mujtaba / Sabna Kotta / Shadab Md / Nabil A. Alhakamy / Hibah M. Aldawsari / Shahid Karim / Abdullah Habeeballah

8.3.2. Dissolution test / Gulam Mustafa / Md Ali Mujtaba / Sabna Kotta / Shadab Md / Nabil A. Alhakamy / Hibah M. Aldawsari / Shahid Karim / Abdullah Habeeballah

8.3.3. Dissolution profile comparisons / Gulam Mustafa / Md Ali Mujtaba / Sabna Kotta / Shadab Md / Nabil A. Alhakamy / Hibah M. Aldawsari / Shahid Karim / Abdullah Habeeballah

8.3.4. Dissolution specification for a new chemical entity / Gulam Mustafa / Md Ali Mujtaba / Sabna Kotta / Shadab Md / Nabil A. Alhakamy / Hibah M. Aldawsari / Shahid Karim / Abdullah Habeeballah

8.3.5. Dissolution specification for generic products / Hibah M. Aldawsari / Shahid Karim / Shadab Md / Nabil A. Alhakamy / Md Ali Mujtaba / Sabna Kotta / Abdullah Habeeballah / Gulam Mustafa

Contents note continued: 8.3.6. Biopharmaceutics classification system / Gulam Mustafa / Md Ali Mujtaba / Sabna Kotta / Shadab Md / Nabil A. Alhakamy / Hibah M. Aldawsari / Shahid Karim / Abdullah Habeeballah

8.4. In vivo performance / Gulam Mustafa / Md Ali Mujtaba / Sabna Kotta / Shadab Md / Nabil A. Alhakamy / Hibah M. Aldawsari / Shahid Karim / Abdullah Habeeballah

8.4.1. In vivo performance evaluation of generic drugs / Gulam Mustafa / Md Ali Mujtaba / Sabna Kotta / Shadab Md / Nabil A. Alhakamy / Hibah M. Aldawsari / Shahid Karim / Abdullah Habeeballah

8.5. Bioavailability and bioequivalence regulatory perspective / Gulam Mustafa / Md Ali Mujtaba / Sabna Kotta / Shadab Md / Nabil A. Alhakamy / Hibah M. Aldawsari / Shahid Karim / Abdullah Habeeballah

8.5.1. Design of bioequivalence studies / Gulam Mustafa / Md Ali Mujtaba / Sabna Kotta / Shadab Md / Nabil A. Alhakamy / Hibah M. Aldawsari / Shahid Karim / Abdullah Habeeballah

8.5.2. Drug interchangeability / Gulam Mustafa / Md Ali Mujtaba / Sabna Kotta / Shadab Md / Nabil A. Alhakamy / Hibah M. Aldawsari / Shahid Karim / Abdullah Habeeballah

8.5.3. Practical issues / Gulam Mustafa / Md Ali Mujtaba / Sabna Kotta / Shadab Md / Nabil A. Alhakamy / Hibah M. Aldawsari / Shahid Karim / Abdullah Habeeballah

8.6. In vitro-in vivo correlation / Hibah M. Aldawsari / Shahid Karim / Shadab Md / Nabil A. Alhakamy / Md Ali Mujtaba / Sabna Kotta / Abdullah Habeeballah / Gulam Mustafa

8.6.1. Advantages of IVIVC / Gulam Mustafa / Md Ali Mujtaba / Sabna Kotta / Shadab Md / Nabil A. Alhakamy / Hibah M. Aldawsari / Shahid Karim / Abdullah Habeeballah

8.6.2. Drawbacks associated with IVIVC / Gulam Mustafa / Md Ali Mujtaba / Sabna Kotta / Shadab Md / Nabil A. Alhakamy / Hibah M. Aldawsari / Shahid Karim / Abdullah Habeeballah

8.6.3. Criteria and classification of IVIVC / Gulam Mustafa / Md Ali Mujtaba / Sabna Kotta / Shadab Md / Nabil A. Alhakamy / Hibah M. Aldawsari / Shahid Karim / Abdullah Habeeballah

8.6.4. Biowaivers / Gulam Mustafa / Md Ali Mujtaba / Sabna Kotta / Shadab Md / Nabil A. Alhakamy / Hibah M. Aldawsari / Shahid Karim / Abdullah Habeeballah

8.7. Scale-up and postapproval changes / Gulam Mustafa / Md Ali Mujtaba / Sabna Kotta / Shadab Md / Nabil A. Alhakamy / Hibah M. Aldawsari / Shahid Karim / Abdullah Habeeballah

8.7.1. EMA guidelines / Gulam Mustafa / Md Ali Mujtaba / Sabna Kotta / Shadab Md / Nabil A. Alhakamy / Hibah M. Aldawsari / Shahid Karim / Abdullah Habeeballah

8.7.2. US FDA guidelines / Gulam Mustafa / Md Ali Mujtaba / Sabna Kotta / Shadab Md / Nabil A. Alhakamy / Hibah M. Aldawsari / Shahid Karim / Abdullah Habeeballah

8.8. Conclusion / Hibah M. Aldawsari / Shahid Karim / Shadab Md / Nabil A. Alhakamy / Md Ali Mujtaba / Sabna Kotta / Abdullah Habeeballah / Gulam Mustafa

References / Gulam Mustafa / Md Ali Mujtaba / Sabna Kotta / Shadab Md / Nabil A. Alhakamy / Hibah M. Aldawsari / Shahid Karim / Abdullah Habeeballah

9.1. Introduction / Mohammad Ahmed Khan / Faraha Ahmed / Syed Sufian Ahmad / Sadat Shafi

9.2. Regulatory submissions of new drugs / Mohammad Ahmed Khan / Faraha Ahmed / Syed Sufian Ahmad / Sadat Shafi

9.2.1. Role of regulatory professionals in regulatory submissions / Mohammad Ahmed Khan / Faraha Ahmed / Syed Sufian Ahmad / Sadat Shafi

9.3. Clinical trial regulation in regulated markets: the United States, Japan and Europe / Mohammad Ahmed Khan / Sadat Shafi / Syed Sufian Ahmad / Faraha Ahmed

9.4. Regulatory collaboration: developing new reliance model / Mohammad Ahmed Khan / Faraha Ahmed / Syed Sufian Ahmad / Sadat Shafi

9.5. Harmonization of clinical trial regulation: principles of ICH-GCP / Mohammad Ahmed Khan / Faraha Ahmed / Syed Sufian Ahmad / Sadat Shafi

9.6. Clinical trial protocol / Mohammad Ahmed Khan / Faraha Ahmed / Syed Sufian Ahmad / Sadat Shafi

9.6.1. Significance of clinical trial protocol / Mohammad Ahmed Khan / Faraha Ahmed / Syed Sufian Ahmad / Sadat Shafi

9.7. Ethical aspect of clinical trial / Mohammad Ahmed Khan / Faraha Ahmed / Syed Sufian Ahmad / Sadat Shafi

9.7.1. Informed consent form / Mohammad Ahmed Khan / Faraha Ahmed / Syed Sufian Ahmad / Sadat Shafi

9.7.2. Exceptions to informed consent / Mohammad Ahmed Khan / Faraha Ahmed / Syed Sufian Ahmad / Sadat Shafi

9.8. Protection of human subjects / Mohammad Ahmed Khan / Faraha Ahmed / Syed Sufian Ahmad / Sadat Shafi

9.8.1. The common rule / Mohammad Ahmed Khan / Faraha Ahmed / Syed Sufian Ahmad / Sadat Shafi

9.8.2. Institutional review board / Mohammad Ahmed Khan / Faraha Ahmed / Syed Sufian Ahmad / Sadat Shafi

9.9. Investigator's brochure / Mohammad Ahmed Khan / Faraha Ahmed / Syed Sufian Ahmad / Sadat Shafi

9.9.1. Contents of investigator's brochure / Mohammad Ahmed Khan / Faraha Ahmed / Syed Sufian Ahmad / Sadat Shafi

9.10. Clinical trial: quality assurance / Mohammad Ahmed Khan / Faraha Ahmed / Syed Sufian Ahmad / Sadat Shafi

9.10.1. Good clinical practice: requirement of quality clinical trial / Mohammad Ahmed Khan / Faraha Ahmed / Syed Sufian Ahmad / Sadat Shafi

9.11. Safety monitoring in clinical trials / Mohammad Ahmed Khan / Faraha Ahmed / Syed Sufian Ahmad / Sadat Shafi

9.11.1. Role of Data and Safety Monitoring Board in monitoring safety in clinical trials / Mohammad Ahmed Khan / Faraha Ahmed / Syed Sufian Ahmad / Sadat Shafi

9.11.2. Role of regulatory authorities in monitoring safety of clinical trials / Mohammad Ahmed Khan / Faraha Ahmed / Syed Sufian Ahmad / Sadat Shafi

9.11.3. Postmarketing surveillance (pharmacovigilance) / Mohammad Ahmed Khan / Faraha Ahmed / Syed Sufian Ahmad / Sadat Shafi

9.11.4. Postmarketing reporting of adverse experiences / Mohammad Ahmed Khan / Sadat Shafi / Syed Sufian Ahmad / Faraha Ahmed

9.12. Outsourcing of clinical trials / Syed Sufian Ahmad / Sadat Shafi / Mohammad Ahmed Khan / Faraha Ahmed

9.12.1. Contract research organizations / Mohammad Ahmed Khan / Sadat Shafi / Faraha Ahmed / Syed Sufian Ahmad

9.12.2. Outsourcing of bioavailability and bioequivalence studies / Mohammad Ahmed Khan / Syed Sufian Ahmad / Sadat Shafi / Faraha Ahmed

9.13. Health Insurance Portability and Accountability Ad / Syed Sufian Ahmad / Sadat Shafi / Mohammad Ahmed Khan / Faraha Ahmed

9.13.1. HIPAA compliance in clinical trials / Syed Sufian Ahmad / Sadat Shafi / Mohammad Ahmed Khan / Faraha Ahmed

9.14. Conclusion / Syed Sufian Ahmad / Sadat Shafi / Mohammad Ahmed Khan / Faraha Ahmed

References / Mohammad Ahmed Khan / Sadat Shafi / Syed Sufian Ahmad / Faraha Ahmed.

Notes:

Includes bibliographical references and index.

Local Notes:

Acquired for the Penn Libraries with assistance from the Edward Potts Cheyney Memorial Fund.

ISBN:

9780128222119

0128222115

OCLC:

1258781998

Publisher Number:

99989315247