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concise Book.pdf - 51.0 MB  Concise Book of Medical Laboratory Technology Methods and Interpretations Ramnik Sood MD (Path, Gold Medalist) Consultant Reem Medical and Diagnostic Center Healthcare Mena Limited Sharjah United Arab Emirates 2nd Edition download  concise Book.pdf Preface to the Second Edition I authored an exhaustive book entitled “Medical Laboratory Technology – Methods and Interpretations” that hit the stands in mid-eighties in the previous century and is now running in its 6th edition. This was the first such book in the subcontinent and was much appreciated and used by technologists and pathologists alike. The book has seen testimonies in courts and has been appreciated in the west too. However, in our subcontinent, I was requested by many technologists that they wanted a little younger sister of the book popularly known as MLT authored by me. And so was born the Concise Book of Medical Laboratory Technology: Methods and Interpretations. The book essentially covers

  Biowavers Biowavers are the exemptions that are granted by USFDA from conducting human bioequivalence studies. Biowavers reduce the need for bioequivalence studies. They are given when in vitro studies data provides sufficient estimate of a relative in vivo performance of two products. These are given when API meets certain solubility and permeability criteria. BIOSTATISTICS IN PHARMACEUTICAL PRODUCT DEVELOPMENT Statistics is the science which deals with collection, tabulation and classification of numerical facts as the basis for explanation, description and comparison of the phenomenon. Biostatistics is the branch of statistics concerned with mathematical facts and data related to biological events. Sir Francis Galton is the Father of biostatistics. There are two types of biostatistics: 1. Inferential biostatistics: It is the methods of generalising a larger group. The generalization is based on information about a sample. The sample is considered to be similar to the population. 2

  10. Quality and Related Concepts 11. Total Quality Management and Other Quality Management Systems 12. ISO Series, NABL and GLP Summary 4 Quality Management Systems 150 Industrial Pharmacy II QUALITY If we go with the dictionary meaning of quality, then quality means “standard of something when compared with one that already exists, or degree of excellence of something.” Quality is something that motivates organisations not only to achieve the minimum excellence mark but also to improve it continuously. Quality of any product depends upon the stakeholders, i.e. their demands and expectations from the products. Here, stakeholder means everyone who has an interest in the product directly or indirectly. Customers comprise a large group of stakeholders. Other stakeholders are investors, employees, suppliers, etc. Quality of any product can be assured by three ways: i. By setting guidelines which are compulsory for an organisation to follow. ii. By setting up an effective quality control

  IND is not required: • In case the drug is not intended for human subjects. • In case the drug is intended for in vivo testing. • When the drug is already approved and study is conducted within the approved indication for use. INVESTIGATOR'S BROCHURE (IB) It is a compilation of the clinical and non-clinical data on the investigational product that is relevant to the study of the product in human subjects. The main purpose of an investigator's brochure is to provide information to the investigator. It also enables the investigator to understand the trial and make benefit/risk assessment of the investigational product by own. The investigational brochure is edited by a medically qualified person. NEW DRUG APPLICATION (NDA) The application through which drug sponsors propose the approval of a new drug product; for marketing in front of regulatory authority. It includes all clinical and non-clinical data. Review time frame: The FDA will review and issue an approval, approvable, o

  Summary 145 NON-CLINICAL DRUG DEVELOPMENT A targeted drug has to go through from various studies such as non-clinical and clinical studies. Non-clinical studies are also known as pre-clinical studies. It is a stage of research that happens before clinical studies. During non-clinical studies important drug safety data is collected. These studies are necessary before filing Investigational New Drug (IND) application. Objectives of Non-clinical Drug Development The main objective of non-clinical study is to confirm that either the target drug is safe for use in human or not. This is done by studying animal pharmacology and toxicology testing. The need for non-clinical studies: Non-clinical studies are essential: • To determine the lethal dose, toxic dose (like LD50, ED50, etc.). • To determine the pharmacological action of the target drug. • It is necessary to submit the animal testing report during the IND application. • To determine the pharmacokinetic properties of a drug. • To dete

  INTRODUCTION Medicines have their existence in parallel with the existence of mankind. It is perhaps as old as a human being. The current pharmaceutical industry is more systematic, well organised and in compliance with respective guidelines. This is because of effective pre- and post-approval regulation of new drugs and the existing drugs. Regulatory affairs play this role for pharmaceutical manufacturing companies and the government of the country. It is a new profession which emerges after government and manufacturing companies felt the need for a bridge in them which promotes coordination and communication. The regulatory affairs act as an interface between government and manufacturing companies. Regulatory affairs is actively involved in every stage of drug development in case of new drug and post-approval surveillance in case of an existing drug. All the applications for getting a pharmaceutical product approved for entering into the market has been prepared by the regulatory d

  REGULATORY AUTHORITIES For every country, the health of its people is of utmost importance. To maintain the health of the people country has to ensure the quality of medicines and other 142 Summary Summary 143 pharmaceutical products as well as devices. So, every country has its regulatory authority which regulates the following: 1. Import of drugs from another country 2. Export of drugs to another country 3. Manufacturing of drugs in the country 4. Establishment of manufacturing companies in the country 5. Dispensing of medicines 6. Approval of new drugs 7. Approval for clinical trials 8. Testing of drugs in the certified laboratories 9. The compliance with international guidelines 10. Regular inspections 11. Issuing various types of licence related to drugs ROLE OF REGULATORY AFFAIRS DEPARTMENT Drug regulatory affairs is a dynamic and challenging field in the pharmaceutical industry. It has to deal with government authority on one hand and applicant/company on another hand. Because

  c. Conducting plant studies d. None of the above 3. IND is required: a. In case the drug is not intended for human subjects. b. In case the drug is intended for in vivo testing. c. When the drug is already approved and study is conducted within the approved indication for use. d. At the time of the clinical trial of an unapproved drug 4. Which CTD module is not required while filing INDA? a. Module 4 b. Module 2 c. Module 3 d. Module 5 5. How many types of INDA are there? a. 2 b. 4 c. 6 d. 3 6. The FDA will review and issue an approval, approvable, or non-approvable letter within 180 days of receipt of application. This time period is known as: a. Filing time frame b. Patent time frame c. Review time frame d. None of the above 7. The term that denotes that a drug substance in two or more identical dosage forms reaches the systemic circulation at the same relative rate and to the same relative extent is known as: a. Bioequivalence b. Bioavailability c. Therapeutic value d. Absorption

  i. To play a lead role in initiating, planning, executing, monitoring and controlling, analysis and reporting a project ii. To communicate and present trial effectively whenever needed iii. To organise and motivate others iv. To manage the trial budget. Effective trial management includes the following: i. Proper planning of the project ii. Time management iii. Timely approval of the trial iv. Proper designing of the clinical trial protocol v. Good collaboration between the trial staff and participants vi. Good communication between each section of the trial pyramid vii. Proper management of the budget viii. Proper training to the staff ix. Appropriate credit will be given to the responsible persons x. Effective recruitment of staff and trial participants xi. Efficient evidence and study in the support of the trial xii. Genuine reporting to the competent authority xiii. Compliance with the regulatory guidelines for clinical trials xiv. Efficient management of the resources xv. Good r

  INDA and NDA 135 Fig. 9.7: Bioequivalence study is the process of estimation of closeness of the effects innovator drug and its generic version. Important pharmacokinetic parameters are: AUC: Area under the concentration–time curve. It is a measure of the extent of absorption. Cmax: It is the observed maximum concentration of a drug. It is a measure of rate and extent of absorption. t max: It is the time at which Cmax is observed. It is a measure of the rate of absorption. Types of bioequivalence studies (Figs 9.8 and 9.9) Fig. 9.8: Types of bioequivalence studies Fig. 9.9: Types of in vivo bioequivalence studies 136 Industrial Pharmacy II Biowavers Biowavers are the exemptions that are granted by USFDA from conducting human bioequivalence studies. Biowavers reduce the need for bioequivalence studies. They are given when in vitro studies data provides sufficient estimate of a relative in vivo performance of two products. These are given when API meets certain solubility and permeabil