eChapters

In any organism and biomolecules (enzyme, proteins, etc.), most biological activities could be seen only within a narrow environmental conditions. Therefore in order to carry out a successful experiment, from cell culturing to DNA sequencing or assessing an enzyme’s activity, one has to pay utmost attention in calculating correct reaction components.

A solution is defined as a homogenous mixture of solute and solvent. In this case the amount solute is less as compared to the solvent. It is not always necessary that solvent is liquid and solute is solid. There are several examples where solute and solvents are found in other physical states such as gas or solids. For example, carbonated water CO₂ is solute and water is solvent; and smoke is solution of different smoke particles (solute) in air (solvent). The concentration of solution is described as amount of solute in a given volume of solvent. Several ways are there to express the concentration of a solution, such as molarity, normality, molality, and ppm. In this chapter we would discuss the general terms used in making solutions and a brief introduction about buffer solutions.

Nucleic acid extraction from clinical samples is the first step to be followed in molecular detection of cancer. Nucleic acids are the starting material for all downstream molecular diagnostic tools. Quality of test results largely depends upon the quality of starting material. Thus utmost importance should be given to the extraction protocols to isolate good quantity and good quality nucleic acids from patient samples.

Basic principle: The basic principle of nucleic acid extraction is to disrupt cell membrane and nuclear membrane to release and precipitate nucleic acid in the solution. Following precipitation,removal of other cellular contaminates such as protein, lipids, polysaccharides etc is performed to obtain a good quantity and quality of nucleic acid.

7.1 Basic concept

What is DNA sequencing?

The genome of any biological organism is a sequence of nucleotides arranged in a specific manner. The nucleotides are chemically a base which usually exists in 4 different forms; Purine – Adenine (A) and Guanine (G) and Pyramidine – Cytosine (C) and Thymine (T). These four nucleotides make up an entire sequence of Deoxyribose Nucleic Acid (DNA) which is encodes the information of any cell in the form of a gene. The genome, therefore, is the complete set of all genes that is required to build and maintain that organism. DNA sequencing is the process wherein the precise order of these nucleotides along the gene is detected and analysed which includes any method or technology that assists in determining the sequence.

4.1    Provisional and Complete Specifications
    
4.2    Publication
    
4.3    Request of Examination
    
4.4    PCT Application: Gateway to Foreign Patents

6.1    Copyrights
    
6.2    Trademarks
    
6.3    Geographical Indications
    
6.4    Trade Secrets

Bone is the only tissue in the body able to heal without microscopical scarring. On the other hand fracture healing is a slow process causing long immobilization periods with consequently high costs for fracture healing giving rise to delayed healing, fibrous healing or non-healing with subsequent problems for both, the patient and the orthopedic surgeon. Fracture healing is complex phenomenon which involves numerous cells, regulators of cell function and biochemical interactions in the repair process. The healing potential of bone, in a fracture model is influenced by a variety of biochemical, biomechanical, cellular, hormonal and pathological mechanisms. A continuous occurring state of bone deposition, resorption and remodeling facilitates the healing process.

Biodegradable and bioinert ceramic materials such as hydroxyapatite (HA), tri­calcium phosphate (TCP), aluminum-calcium-phosphate (ALCAP) ceramics provides scaffold to support the attachment and migration of newly formed bone cells into the osseous defect and also help in formation of a vascular network through the newly formed bone. Bioceramic also act as a carrier to deliver stem cells for osteogenesis.

Specific bone-inductive proteins/growth factors can induce bone formation and healing in vivo. These morphogens are therefore, to be an ideal alternative to autogenous bone grafts. These findings initiating intensive research into bone regeneration orchestrated by putative soluble signals and lead to the discovery and identification of an entirely novel family of protein initiators collectively called the bone morphogenic protein (BMPs), which belong to transforming growth factors-ß (TGF- ß) super family. These growth factors might possess a biological activity that is site and tissue specific in the induction of bone formation. Different growth factors have been demonstrated to possess osteoinductive and fracture healing properties.

True/False
 
Q.1.    The set of observations or measurements collected on specific characteristics from each item (individual) constitutes data.
Q.2.    Each characteristic that is measured or observed, varies from item to item and is called “Variable”.
Q.3.    “Blood type”, “stage of disease” and “weight” observed on a group of cancer patients, are three distinct variables.
Q.4.    A variable that can be expressed in numbers such as age, height, blood pressure, is said to be “Quantitative variable”.

True/False

Q.1.    The set of all possible outcomes of a variable along with the frequency (the number of occurrence) of each outcome or a group of outcome is called “Frequency Distribution”.
Q.2.    The frequency of an occurrence of each outcome of a trail divided by total frequency is known as “Relative frequency” of the outcome.
Q.3.    The distribution of total probability “1” into probabilities of occurrence of each outcome of a trial, is known as probability distribution of the outcome.

True/False

Q.1.    Collectivity (totality) of all sampling units is known as the “Population” and population size is denoted by “N”.
Q.2.    A list of all sampling units with their identification is known as “Sampling frame”. For example a list of all newly-born children in maternity home during a period of three months with specification of their sex, weight, name of their parents, their permanent address, etc. is known as sampling frame.
Q.3.    A function of all sampling units in the population is known as population parameter or population constant.

True/False

Q.1.    The process of knowing all the relevant information from the known sample to the unknown “Population parameter” is known as “Statistical inference.”
Q.2.    The method of estimating the unknown parameter of the population on the basis of known sample values is known “Estimation method.”
Q.3.    The “Point estimation and Interval estimation” are the two methods of estimating the unknown parameters of the population.

Introduction

The sex of the animal is one of the most easily observable attributes of a livestock population. The importance of the sex ratio lies in the fact that it sets the future rates of fertility, mortality, and migration. In livestock, male animals are required in fewer numbers compared to females for breeding. So, for profitable management of a farm, the sex ratio has been fixed for each species. But because of the natural 50:50 chance of both types of sperms to fertilize an ovum, this preferred sex ratio is never achieved. In order to reach this economical ratio, additional efforts must be done in the form of culling. Moreover, in monotocous species with nearly one year gestation period, a long wait is sometimes required for getting the offspring of particular sex.

In dairy farming, the number of female offspring born is always an asset to the farm. For the species reared for meat, the males are often avoided due to the intense odor of their meat and handling difficulty while rearing. But when there is shortage of good quality breeding bulls, the sorted sperms will be helpful for producing the elite bulls for breeding. If we can produce only the animal of the desired gender, we can eliminate split-sex feeding, reduce problems related to animal welfare and castration, improve production efficiencies. Additionally, the costs of the progeny testing programme and embryo transfer are reduced as a result, and the value of genetic markers is increased. Apart from the livestock species, sex pre-selection is also important in breeding of companion animals, zoo animals and endangered species.

True/False

Q.1.    In clinical practice and in public health, the objective is to find better ways to ‘prevent,  diagnose and treat disease’.
Q.2.    Among all research designs, experimental study designs are the most reliable and  ideal designs to evaluate the ‘effectiveness or value’ of interventions (like drugs,  medication etc.) for human disease and disabilities.

ABSTRACT

The concept and nature of intellectual property have undergone a paradigm shift during the last few decades. The importance of effective IPR governance has attracted the attention of its stakeholders. Hence, this paper focuses on the role of IPR governance and management practices for improving the quality of relationships among stakeholders besides documenting current and future trends of IPR governance and management.

INTELLECTUAL PROPERTY RIGHTS – AN INTRODUCTION

Intellectual property rights refer to the privileges granted by the government to any individual or organization for creative prowess. In recent years, such rights have gained immense importance. The laws in existence for protection and enforcement of these rights are meant to foster innovation and for regulating the use of inventions.

True/False

Q.1.    In many clinical research studies, the regression analysis is used to develop models for prediction of an outcome from one or more explanatory variables.
Q.2.    Now a days, the linear, logistic and Cox (proportional hazards) regression models are used frequently in medical research.

Livestock breeding for genetic improvement faces many challenges including feed conversion efficiency, fertility and adaptation to changing climate. These improvements have to be realized while maintaining or improving the nutritional properties of meat, milk and other animal products while giving emphasis to animal health and wellbeing also. Environmental stresses induced by climate change affect livestock productivity, reproductive efficiency and health, resulting in severe economic losses. Under the current climate change scenario, the viability of producing animals for human consumption is in jeopardy. In order to lessen the negative effects of heat stress in today’s world, it is urgently necessary to develop methods that are centered on breeding animals with increased thermal tolerance and climate resilience. The breeding of animals having genetic potential to sustain under changing environment conditions can be achieved through the various molecular genetics tools.

Biostatistics is a branch of statistics that focuses on the analysis and interpretation of data from biological and health-related research studies. It involves the application of statistical methods to design, collect, analyze, and interpret data from studies involving living organisms like: animals, birds including human beings. Biostatistics plays a crucial role in public health, medicine, epidemiology, genetics, and other related fields.

With the increasing availability of data and advancements in biostatistics, breeders can expect further improvements in breeding practices that will results in better outcomes for both livestock farmers and the animals they breed. Animal breeding is a crucial aspect of agriculture and food production, as it helps to improve the quality and quantity of animal products as well ensuring food security to the masses.

Checks and Balances in Biotechnology Applications
    
Biosafety Issues in Animal Biotechnology Application
    
World Organization for Animal Health (OIE)
    
Recombinant DNA Safety Guidelines (1990)
    
Foreign Trade (Development and Regulation) Act, 1992 (2006)(Draft Amendment)
    
Revised Guidelines for Research in Transgenic Plants and Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds, Plants and Plant Parts (1998)
    
Guidelines for Generating Preclinical and Clinical Data for rDNA Vaccines, Diagnostics and other Biologicals (1999)
    
The Food Safety and Standards Act (2006)
    
Transgenic Animals Bioreactors
    
First Patent in Biotechnology
    
Biotechnology - Ethical Concerns
    
Some Priority Areas in the Field of Biotechnology
    
Suggestions for Future Development of Biotechnology Activities in the Field of Animal Health and Production in India
    
Epilogue

Animal Science Biotechnology Research Centres
    
Current Status and Some of the Achievements in Animal Heatlh
    
National Bioresource Development Board
    
Animal Biotechnology
    
Biotechnology Parks and Incubators
    
National Institute of Immunology, New Delhi
    
Bose Institute, Kolkata
    
Jawahar Lal Nehru University, New Delhi
    
National Centre For Cell Science, Pune
    
Centre for Dna Fingerprinting and Diagnostics (Cdfd) Hyderabad
    
National Institute for Plant Genome Research (Nipgr) New Delhi
    
Institute of Bioresources and Sustainable Development,Imphal
    
Institute of Life Sciences, Bhubaneshwar
    
Bharat Immunologicals and Biologicals Corporation Limited
    
International Centre for Genetic Engineering and Biotechnolgoy (Icgeb), New Delhi
    
Animal Biotechnology Research Abroad

1. Introduction
Good Laboratory Practice (GLP) is a systematic quality system essential for
ensuring the reliability, consistency, and integrity of laboratory data, particularly when the findings are used for regulatory decision-making. GLP ensures that laboratory studies are conducted in a scientific manner, maintaining high standards of ethical practice, precision, and reproducibility, with a primary focus on ensuring public and environmental safety. Introduced by the U.S. Food and Drug Administration (FDA) in 1978, GLP gained global recognition through the Organisation for Economic Cooperation and Development (OECD), which established guidelines for its implementation. GLP principles are now widely adopted in regulatory testing for pharmaceuticals, chemicals, food safety, and environmental testing. The OECD’s guidance on GLP has been instrumental in developing standards across the globe, ensuring that test results are scientifically valid and can be accepted internationally. In Asia, particularly in India and other developing countries, GLP compliance has gained increasing importance as pharmaceutical, environmental, and chemical industries expand. Regulatory bodies in these regions have gradually aligned their standards with international norms to ensure their competitiveness in global markets. This chapter discusses the key SOPs necessary for GLP compliance and provides a regional perspective, focusing on India and other Asian nations, where GLP frameworks are evolving to meet international standards.
2. Objective of GLP
The overarching objective of GLP is to ensure that laboratory data is accurate, reliable, and reproducible across different studies. The scientific and regulatory communities rely on GLP to ensure that findings from preclinical studies and safety evaluations can be trusted and utilized for regulatory approval.
The key objectives of GLP include
• Accuracy and Integrity of Data: GLP ensures that every aspect of data collection, analysis, and reporting is conducted with integrity and accuracy, preventing errors or falsification that could affect regulatory decisions.

Introduction
According to the U.S. Food and Drug Administration (FDA), Good Laboratory Practices (GLP) is a quality system that ensures the nonclinical safety studies are appropriately designed, conducted, and documented to generate reliable data. The laboratory techniques are defined as the processes and practices that are recommended for equipment use in the laboratory, while laboratory methods are based on established scientific principles involving biology, chemistry, and physics, and encompass all aspects of the clinical laboratory from testing the amount of cholesterol in blood to analysing DNA to growing microscopic organisms that may be causing an infection. One of the most significant parts of laboratory techniques and laboratory methods is the proper validation of the equipments (old or new equipments) as well as all the testing procedures/ methods (established or newly developed methods). Analytical method validation is a critical process to ensure the quality and safety of products. The objective of the validation of an analytical method is to demonstrate that it is suitable for its intended purpose; the results are authentic and universally acceptable. An analytical method is suitably well considered when the results generated through different method are consistent, reproducible, and thus, reliable.
The validation is required when
• A new method has been developed
• Revision of established method
• Use of established methods in different laboratories and different analysts, etc.
• Comparison of methods required
• When quality control indicates method changes